Airuituo (bevacizumab biosimilar)
/ Jiangsu Hengrui Pharma
- LARVOL DELTA
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January 12, 2024
Optimising first-line subtyping-based therapy in triple-negative breast cancer (FUTURE-SUPER): a multi-cohort, randomised, phase 2 trial.
(PubMed, Lancet Oncol)
- P2 | "These findings highlight the potential clinical benefits of using molecular subtype-based treatment optimisation in patients with triple-negative breast cancer, suggesting a path for further clinical investigation. Phase 3 randomised clinical trials assessing the efficacy of subtyping-based regimens are now underway."
Journal • P2 data • Breast Cancer • Hematological Disorders • HER2 Breast Cancer • Neutropenia • Oncology • Solid Tumor • Triple Negative Breast Cancer • AR • HER-2
July 24, 2025
Phase III study of camrelizumab plus famitinib versus platinum-based chemotherapy as first-line therapy for recurrent or metastatic cervical cancer
(ESMO 2025)
- P3 | "Methods In this multicenter, phase 3 study, pts were randomized (1:1) to receive either CAM (200 mg, iv, Q3W) plus FAM (20 mg, po, qd) or investigator's choice of chemo (paclitaxel + cisplatin/carboplatin, with/without bevacizumab). TRAE led to discontinuation of any treatment in 13.6% with CAM + FAM and 6.6% with chemo. Conclusions This chemo-free regimen of CAM plus FAM significantly prolongs PFS and OS compared with platinum-based chemo with/without bevacizumab as first-line treatment in pts with R/M CC, with a tolerable safety profile."
Clinical • Late-breaking abstract • Metastases • P3 data • Cervical Cancer • Gynecologic Cancers • Oncology • PD-L1
July 16, 2024
SHR-A1921 in platinum-resistant ovarian cancer (PROC): data from a first-in-human (FIH) phase I study
(ESMO 2024)
- P1 | "Most pts had received prior bevacizumab (69.6%) and PARP inhibitors (58.7%). SHR-A1921 demonstrated promising efficacy with a manageable safety profile in heavily pretreated pts with PROC. A pivotal phase 3 study is currently in preparation."
P1 data • Oncology • Ovarian Cancer • Solid Tumor • TACSTD2
June 26, 2025
Utidelone Plus Bevacizumab for ERBB2-Negative Metastatic Breast Cancer and Active Brain Metastases: The U-BOMB Phase 2 Nonrandomized Clinical Trial.
(PubMed, JAMA Oncol)
- P2 | "This treatment approach warrants further validation in a randomized clinical trial. ClinicalTrials.gov Identifier: NCT05357417."
Clinical • Journal • P2 data • Brain Cancer • Breast Cancer • HER2 Breast Cancer • HER2 Negative Breast Cancer • HER2 Positive Breast Cancer • Oncology • Solid Tumor • HER-2
September 08, 2026
Hepatic arterial infusion or intravenous infusion of adebrelimab, combined with bevacizumab and HAIC of the FOLFOX regimen for advanced unresectable hepatocellular carcinoma (HAIBrave-001 trial): a study protocol of a prospective, double-arm, phase II trial.
(PubMed, J Gastrointest Oncol)
- P2 | "Although atezolizumab plus bevacizumab is recommended as a first-line treatment for advanced unresectable hepatocellular carcinoma (HCC), its objective response rate (ORR) remains only about 30%...These findings will determine whether either regimen warrants further investigation, optimize immunotherapy delivery routes, and inform the design of future phase III comparative trials. ClinicalTrials.gov (NCT06737913)."
IO biomarker • Journal • P2 data • Hepatocellular Cancer • Liver Cancer • Oncology • Solid Tumor
April 21, 2026
Impact of bevacizumab on the efficacy of antibody–drug conjugates as later-line treatment of basal-like immune-suppressed triple-negative breast cancer.
(ASCO 2026)
- P2 | "In arm C, patients received either SHR-A1811 (anti-HER2 ADC, 4.8 mg/kg IV q3w) alone (C1) or with bevacizumab (15 mg/kg IV q3w) (C2). In arm D, patients received either SHR-A1921 (Trop2-targeted ADC, 3.0 mg/kg IV q3w) alone (D1) or with bevacizumab (7.5 mg/kg IV q3w) (D2)... This study provides preliminary evidence of synergy between bevacizumab and ADCs, supporting a promising new strategy—especially for basal-like, immune-suppressed TNBC. Phase III trials are ongoing to confirm the efficacy and safety of this combination. The efficacy table."
ADC • Clinical • Breast Cancer • HER2 Breast Cancer • HER2 Positive Breast Cancer • Oncology • Solid Tumor • Triple Negative Breast Cancer
April 23, 2025
A phase II clinical study of adebrelimab and bevacizumab combined with cisplatin/carboplatin in triple-negative breast cancer patients with brain metastases.
(ASCO 2025)
- P2 | "The triplet treatment of anti-PD-L1 Adebrelimab, bevacizumab and cisplatin/carboplatin, was the first regimen demonstrating a high intracranial anti-tumor activity, a prolonged CNS-PFS and OS with a good safety profile. Warranting further investigation in this highly aggressive disease. Clinical trial information: NCT04303988."
Clinical • P2 data • Breast Cancer • Neutropenia • Oncology • Solid Tumor • Triple Negative Breast Cancer
April 23, 2025
HER2-ADC trastuzumab rezetecan (SHR-A1811) in HER2-positive breast cancer with brain metastases: Update results from REIN trial.
(ASCO 2025)
- P2 | "Funded by No funding sources reported Clinical Trial Registration Number: NCT05769010 Background: HER2-directed antibody-drug conjugates (ADCs) have been demonstrated to be of intracranial activity in patients with HER2+ breast cancer (BC) with brain metastases (BM). Our findings showed that SHR-A1811 6.4 mg/kg solely or SHR-A1811 4.8 mg/kg combined with bevacizumab both can attain high intracranial remission rates, while the lower-dose combination regimen might exhibit a better safety profile. The long-term outcomes will continue to be followed up."
Anemia • Brain Cancer • Breast Cancer • HER2 Breast Cancer • HER2 Positive Breast Cancer • Oncology • Solid Tumor • HER-2
April 21, 2026
SHR-A1811 plus chemotherapy and BP102 as 1L therapy for HER2-expressing mCRC: Data from a phase Ib/II study.
(ASCO 2026)
- P1/2 | " This open-label, multicenter phase Ib/II study (ClinicalTrials.gov: NCT06015048) used an i3+3 design in phase Ib to evaluate the safety and tolerability of SHR-A1811 + 5-FU/L-LV, ± oxaliplatin and/or BP102, and to select the phase II regimen... SHR-A1811 plus chemotherapy and BP102 as 1L therapy for HER2 intermediate or high-expressing mCRC demonstrated manageable safety and encouraging antitumor activity."
P1/2 data • Colorectal Cancer • Dental Disorders • Hematological Disorders • Stomatitis • BRAF • HER-2
February 05, 2026
SHR-A2009, a HER3-targeted ADC, plus bevacizumab (Bev) for pretreated EGFR-mutated non-squamous (EGFRm nsq) NSCLC: A phase Ib/II study
(ELCC 2026)
- P1/2 | "Table: 23P Efficacy outcomes SHR-A2009 8.0 mg/kg + Bev 7.5 mg/kg (n=30) SHR-A2009 8.0 mg/kg + Bev 15 mg/kg (n=31) All SHR-A2009 8.0 mg/kg + Bev (n=61) Confirmed ORR (n/N; 95% CI), % 56.7 (17/30; 37.4–74.5) 61.3 (19/31; 42.2–78.2) 59.0 (36/61; 45.7–71.4) DCR (n/N; 95% CI), % 90.0 (27/30; 73.5–97.9) 93.5 (29/31; 78.6–99.2) 91.8 (56/61; 81.9–97.3) Median DoR (95% CI), mo 10.4 (4.5–NR) 14.7 (12.5–NR) 14.7 (9.5–NR) Ongoing response, % (n/N) 52.9 (9/17) 78.9 (15/19) 66.7 (24/36) PFS Event, n (%) 14 (46.7) 10 (32.3) 24 (39.3) Median (95% CI), mo 11.8 (8.5–NR) 10.9 (8.5–NR) 11.8 (10.8–NR) Median follow-up (range), mo 12.9 (1.1–18.7) 7.9 (2.2–17.4) 10.9 (1.1–18.7) DCR, disease control rate; NR, not reached; ORR, objective response rate; PFS, progression-free survival. Conclusions SHR-A2009 + Bev demonstrated manageable safety with encouraging activity in EGFRm nsqNSCLC progressing after EGFR-TKI therapy."
ADC • P1/2 data • Lung Cancer • Lung Non-Squamous Non-Small Cell Cancer • Non Small Cell Lung Cancer • Solid Tumor • EGFR • ERBB3
March 04, 2026
Phase II Clinical Study of Adebrelimab and Bevacizumab Combined With Cisplatin/Carboplatin in Patients With Triple-Negative Breast Cancer With Brain Metastases (ABC Study).
(PubMed, J Clin Oncol)
- "The combination of adebrelimab, bevacizumab, and cisplatin/carboplatin was the first regimen to demonstrate promising intracranial antitumor activity and prolonged PFS and CNS-PFS, along with a manageable safety profile, warranting further investigation."
Journal • P2 data • Breast Cancer • Oncology • Solid Tumor • Triple Negative Breast Cancer
November 25, 2025
Fuzuloparib with or without apatinib as maintenance therapy in newly diagnosed, advanced ovarian cancer (FZOCUS-1): A multicenter, randomized, double-blind, placebo-controlled phase 3 trial.
(PubMed, CA Cancer J Clin)
- "Although poly(adenosine diphosphate-ribose) polymerase inhibitors (PARPis) and bevacizumab were approved as first-line maintenance for advanced ovarian cancer (OC), evidence comparing this combination with PARPi monotherapy, especially in BRCA-mutated/homologous recombination-deficient (HRD) patients, is lacking. Adding apatinib to fuzuloparib did not prolong PFS among homologous recombination-deficient patients. There was a PFS benefit trend among homologous recombination-proficient patients who received combination therapy compared with those who received monotherapy."
Clinical • Journal • P3 data • Gynecologic Cancers • Oncology • Ovarian Cancer • Solid Tumor • BRCA • BRCA1 • BRCA2 • HRD
October 31, 2025
Exploratory Study of Albumin-Bound Paclitaxel, Platinum, and Bevacizumab in EGFR-Mutant NSCLC with SCLC Transformation Post-EGFR-TKI Resistance
(ChiCTR)
- P1 | N=8 | Not yet recruiting | Sponsor: Zhejiang Cancer Hospital; Zhejiang Cancer Hospital
New P1 trial • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Small Cell Lung Cancer • Solid Tumor
April 23, 2025
SHR-8068 plus adebrelimab and bevacizumab for advanced hepatocellular carcinoma (aHCC): A phase 1b/2 study.
(ASCO 2025)
- P1/2, P3 | "SHR-8068 combined with adebrelimab and bevacizumab showed promising efficacy and manageable safety in aHCC. A more favorable benefit-risk profile was observed for SHR-8068 given as a priming dose. A phase 3 trial (NCT06618664) is currently underway to further assess the combination as 1L treatment for aHCC."
Metastases • P1/2 data • Cardiovascular • Hepatocellular Cancer • Hypertension • Oncology • Solid Tumor
December 16, 2024
Addition of SHR-1701 to first-line capecitabine and oxaliplatin (XELOX) plus bevacizumab for unresectable metastatic colorectal cancer.
(PubMed, Signal Transduct Target Ther)
- P2/3 | "Elevated baseline lactate dehydrogenase was linked to shorter PFS. SHR-1701 combined with XELOX and bevacizumab demonstrated a manageable safety profile and potent antitumor activity in unresectable mCRC."
IO biomarker • Journal • Metastases • Tumor mutational burden • Colorectal Adenocarcinoma • Colorectal Cancer • Hematological Disorders • Neutropenia • Oncology • Solid Tumor • TGFB1 • TMB
October 24, 2024
SHR-8068 combined with adebrelimab and bevacizumab in the treatment of refractory advanced colorectal cancer: study protocol for a single-arm, phase Ib/II study.
(PubMed, Front Immunol)
- "This proof-of-concept study would provide safety and efficacy signals of this novel combination treatment for the MSS CRCs in the late-line setting. And it may offer new insights on the clinical application of dual immunotherapy combined with anti-angiogenic therapy in the MSS CRC."
Clinical protocol • IO biomarker • Journal • Metastases • P1/2 data • Colorectal Adenocarcinoma • Colorectal Cancer • Gastrointestinal Cancer • Microsatellite Instability • Oncology • Solid Tumor • MSI
November 20, 2017
Combination Chemotherapy, Bevacizumab, and/or Atezolizumab in Treating Patients With Deficient DNA Mismatch Repair Metastatic Colorectal Cancer, the COMMIT Study
(clinicaltrials.gov)
- P3; N=347; Recruiting; Sponsor: National Cancer Institute (NCI); Not yet recruiting ➔ Recruiting; N=439 ➔ 347
Clinical • Enrollment change • Enrollment open • IO biomarker • Mismatch repair • Monotherapy • Colon Cancer • Colorectal Adenocarcinoma • Colorectal Cancer • Gastrointestinal Cancer • Microsatellite Instability • Oncology • Solid Tumor • BRAF • MLH1 • MSH2 • MSH6 • MSI • PCR
May 21, 2020
Combination Chemotherapy, Bevacizumab, and/or Atezolizumab in Treating Patients With Deficient DNA Mismatch Repair Metastatic Colorectal Cancer, the COMMIT Study
(clinicaltrials.gov)
- P3; N=200; Recruiting; Sponsor: National Cancer Institute (NCI); N=347 ➔ 200
Clinical • Enrollment change • IO biomarker • Mismatch repair • Colon Cancer • Colorectal Adenocarcinoma • Colorectal Cancer • Gastrointestinal Cancer • Microsatellite Instability • Oncology • Solid Tumor • BRAF • MLH1 • MSH2 • MSH6 • MSI • PCR
February 02, 2021
Combination Chemotherapy, Bevacizumab, and/or Atezolizumab in Treating Patients With Deficient DNA Mismatch Repair Metastatic Colorectal Cancer, the COMMIT Study
(clinicaltrials.gov)
- P3; N=231; Recruiting; Sponsor: National Cancer Institute (NCI); Suspended ➔ Recruiting
Clinical • Enrollment open • IO biomarker • Mismatch repair • Colon Cancer • Colorectal Adenocarcinoma • Colorectal Cancer • Gastrointestinal Cancer • Microsatellite Instability • Oncology • Solid Tumor • BRAF • MLH1 • MSH2 • MSH6 • MSI • PCR
June 11, 2020
Combination Chemotherapy, Bevacizumab, and/or Atezolizumab in Treating Patients With Deficient DNA Mismatch Repair Metastatic Colorectal Cancer, the COMMIT Study
(clinicaltrials.gov)
- P3; N=200; Suspended; Sponsor: National Cancer Institute (NCI); Recruiting ➔ Suspended
Clinical • IO biomarker • Mismatch repair • Trial suspension • Colon Cancer • Colorectal Adenocarcinoma • Colorectal Cancer • Gastrointestinal Cancer • Microsatellite Instability • Oncology • Solid Tumor • BRAF • MLH1 • MSH2 • MSH6 • MSI • PCR
April 25, 2024
A phase II trial combining SHR-1316, bevacizumab, and cisplatin/carboplatin in patients with TNBC with active brain metastases.
(ASCO 2024)
- P2 | "SHR-1316 plus bevacizumab and cisplatin/carboplatin achieves a significant improvement in CNS ORR and brings PFS and OS benefits in TNBC patients with active BMs. As an effective and safe treatment, this triple-combination warrants further investigation. Clinical trial information: NCT04303988."
Clinical • P2 data • Anemia • Cardiovascular • Hematological Disorders • Hypertension • Leukopenia • Neutropenia • Oncology • Solid Tumor • Triple Negative Breast Cancer
April 25, 2024
Efficacy and safety of HER2-ADC SHR-A1811 in HER2-positive breast cancer with brain metastases.
(ASCO 2024)
- P2 | " Patients with radiotherapy-naïve HER2-expressing BCBM, and not in need of immediate local treatment were enrolled, and they received SHR-A1811 as monotherapy (Arm 1 HER2+ and Arm 4 HER2-low) or in combination with pyrotinib or bevacizumab (Arm 2 and Arm 3 HER2+) until disease progression, unaccepted toxicity, or no further benefit. Our interim results showed an inspiring intracranial response rate and an acceptable tolerance of the novel ADC SHR-A1811 in HER2+ BCBM. The enrollment of this study is ongoing, and the long-term outcomes will be followed up. Clinical trial information: NCT05769010."
Clinical • Anemia • Breast Cancer • Hematological Disorders • HER2 Breast Cancer • HER2 Positive Breast Cancer • Oncology • Solid Tumor • HER-2
November 04, 2023
Famitinib, a multi-targeted receptor tyrosine kinase inhibitor, combined with dalpicilib and fulvestrant in advanced HR-positive and HER2-negative breast cancer
(SABCS 2023)
- P1/2 | "However, the role of angiogenesis inhibitors, such as bevacizumab, in these patients (pts) is controversial...Our phase Ib/II trial (NCT05176080, ChiCTR2100053950) aims to evaluate the safety and efficacy of a novel anti-angiogenesis TKI famitinib (F) added to dalpiciclib (D) and ET in advanced HR-positive and HER2-negative BC... The anti-angiogenesis multi-targeted receptor TKI famitinib combined with CDK4/6i and fulvestrant has shown antitumor effects in advanced HR-positive and HER2-negative BC, and no new safety signals were observed."
Metastases • Breast Cancer • HER2 Breast Cancer • HER2 Negative Breast Cancer • Hormone Receptor Positive Breast Cancer • Oncology • Solid Tumor • HER-2
November 16, 2023
Efficacy, safety and pharmacokinetics of apatinib plus etoposide versus apatinib alone for platinum-resistant recurrent ovarian cancer: protocol of a multicenter, open-label, randomized phase 2 trial.
(PubMed, Transl Cancer Res)
- P2 | "Currently preferred single-agent nonplatinum chemotherapy or its combination with bevacizumab results in a low response rate and modest survival benefit for platinum-resistant recurrent ovarian cancer, and thus more effective regimens are needed. ClinicalTrials.gov Identifier: NCT04383977. It was registered on May 12, 2020."
Journal • P2 data • PK/PD data • Oncology • Ovarian Cancer • Solid Tumor
July 27, 2023
SHR-1701 in combination with BP102 and XELOX as first-line (1L) treatment for patients (pts) with unresectable metastatic colorectal cancer (mCRC): Data from a phase II/III study
(ESMO 2023)
- P2/3 | "Background The standard 1L therapies for mCRC involve a fluoropyrimidine with oxaliplatin and/or irinotecan, and a biologic agent. Median PFS was 10.3 months (95% CI, 8.3-13.7), and median OS was immature. Conclusions SHR-1701 in combination with BP102 and XELOX as 1L treatment provided a manageable safety profile and potent antitumor activity in pts with unresectable mCRC."
Clinical • Combination therapy • IO biomarker • Metastases • P2/3 data • Colorectal Cancer • Gastrointestinal Cancer • Oncology • Solid Tumor • BRAF • RAS • TGFB1
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