IBI-354 / Innovent Biologics - LARVOL DELTA

A Phase II, Single-Center Study Evaluating IBI354 as Neoadjuvant Therapy for HER2-Positive Advanced Epithelial Ovarian Cancer (ChiCTR) - P2 | N=31 | Not yet recruiting | Sponsor: Zhejiang Cancer Hospital; Zhejiang Cancer Hospital

New P2 trial • Epithelial Ovarian Cancer • Fallopian Tube Cancer • Lung Cancer • Oncology • Ovarian Cancer • Peritoneal Cancer • Solid Tumor • HER-2

IBI354, an anti-HER2 antibody-drug conjugate, in patients with locally advanced unresectable or metastatic ovarian cancers: Updated results from a phase I trial. (ASCO 2025) - P1/2 | "Funded by No funding sources reported Clinical Trial Registration Number: NCT05636215 Background: IBI354 is an antibody-drug conjugate consisting of trastuzumab (anti-HER2 antibody) conjugated to a topoisomerase I inhibitor. IBI354 was well tolerated with a manageable safety profile and showed promising efficacy in pts with locally advanced unresectable or metastatic OC, especially in pts with HER2 lower expression."

Clinical • Metastases • P1 data • Anemia • Interstitial Lung Disease • Oncology • Ovarian Cancer • Pneumonia • Pulmonary Disease • Respiratory Diseases • Solid Tumor

IBI354 (anti-HER2 antibody-drug conjugate [ADC]) in patients (pts) with HER2-positive breast cancer (BC) and other solid tumors: Updates from a phase 1 study. (ASCO 2025) - P1/2 | "IBI354 consists of trastuzumab (anti-HER2 antibody) conjugated to a camptothecin derivative... IBI354 continues to demonstrate favorable safety profiles with no new safety signals. Encouraging efficacy was observed in HER2-positive BC."

Clinical • P1 data • Anemia • Breast Cancer • HER2 Breast Cancer • HER2 Positive Breast Cancer • Interstitial Lung Disease • Oncology • Pulmonary Disease • Respiratory Diseases • Solid Tumor

2025 ASCO Presentation: Innovent Biologics Announces Updated Data of IBI354 (Novel anti-HER2 ADC) From the Phase 1/2 Clinical Study in Advanced Ovarian Cancer, Breast Cancer and Other Solid Tumors (PRNewswire) - P1/2 | N=368 | NCT05636215 | Sponsor: Innovent Biologics (Suzhou) Co. Ltd. | "In HER2-positive breast cancer cohort (n= 88, treated at 6~15mg/kg, the median prior treatment lines was 4), the confirmed objective response rate (ORR) and the disease control rate (DCR) were 59.1% and 90.9%, respectively. In 9 mg/kg Q3W subgroup (n=29), the ORR and the DCR were 72.4% and 89.7%, respectively. The median progression-free survival (PFS) was 14.1 months (95% CI: 8.3-not calculable [NC]) with events of 48.3%. The median overall survival (OS) was immature with events of 3.4%. In ovarian cancer cohort (n=92, treated at 2~12mg/kg, the median prior treatment lines was 3), the cORR was 41.2% and the DCR was 82.0%. In the 12mg/kg Q3W subgroup (n=40), the cORR reached 55.0% and the DCR was 90.0%. In participants with HER2 1+ (n=27), the ORR reached 55.6% and the DCR was 88.9%."

P1 data • Platinum resistant • HER2 Positive Breast Cancer • Ovarian Cancer

HeriCare-Ovarian01: Study of IBI354 Versus Investigator's Choice of Chemotherapy in Patients With Platinum-resistant Ovarian, Primary Peritoneal, or Fallopian Tube Cancer (clinicaltrials.gov) - P3 | N=450 | Recruiting | Sponsor: Innovent Biologics (Suzhou) Co. Ltd. | Not yet recruiting ➔ Recruiting

Enrollment open • Platinum resistant • Fallopian Tube Cancer • Oncology

Innovent Dosed First Participant in Phase 3 Clinical Study of IBI354 (Novel HER2 ADC) for Platinum-resistant Ovarian Cancer (PRNewswire) - "Innovent Biologics...announces that the first participant has been successfully dosed with IBI354 (HER2 Monoclonal Antibody-Camptothecin Derivative Conjugate, HER2 ADC) in a randomized, controlled, multicenter Phase 3 clinical trial (HeriCare-Ovarian01), for platinum-resistant ovarian cancer (PROC) with HER2 expression. HeriCare-Ovarian01 is the first Phase 3 clinical trial (NCT06834672) in China to investigate PROC with HER2 expression (IHC 1+, 2+ or 3+). The study will evaluate the safety and efficacy of IBI354, compared with investigator's choice of chemotherapy for PROC with HER2 expression. The primary endpoints are progression-free survival (PFS) and overall survival (OS)."

Trial status • Ovarian Cancer

Study of IBI354 Versus Investigator's Choice of Chemotherapy in Patients With Platinum-resistant Ovarian, Primary Peritoneal, or Fallopian Tube Cancer (clinicaltrials.gov) - P3 | N=450 | Not yet recruiting | Sponsor: Innovent Biologics (Suzhou) Co. Ltd.

New P3 trial • Fallopian Tube Cancer • Oncology

Innovent Biologics' HER2 ADC to be included in Breakthrough Therapy Designation for platinum-resistant ovarian cancer [Google translation] (Sohu.com) - "On December 2, the CDE network showed that Innovent Biologics' IBI354 is planned to be included in the breakthrough therapy for the treatment of platinum-resistant ovarian cancer with HER2 expression (IHC1+, 2+ or 3+)."

Breakthrough therapy • Gynecologic Cancers • Oncology • Ovarian Cancer • Solid Tumor • HER-2

CIBI354A101: A First-in-human Study of IBI354 in Subjects With Locally Advanced Unresectable or Metastatic Solid Tumors (clinicaltrials.gov) - P1/2 | N=368 | Recruiting | Sponsor: Innovent Biologics (Suzhou) Co. Ltd. | Not yet recruiting ➔ Recruiting | Trial completion date: Jul 2025 ➔ Oct 2025 | Trial primary completion date: Oct 2024 ➔ Apr 2025

Enrollment open • Metastases • Trial completion date • Trial primary completion date • Biliary Tract Cancer • Breast Cancer • Colorectal Cancer • Gastric Cancer • Gynecologic Cancers • Oncology • Solid Tumor • HER-2

Safety and efficacy of IBI354 (anti-HER2 ADC) in patients (pts) with advanced gastrointestinal (GI) cancers: Results from a phase I study (ESMO 2024) - P1/2 | "Background: IBI354, an antibody-drug conjugate (ADC), composed of trastuzumab (anti-HER2 antibody) conjugated to a topoisomerase I inhibitor. IBI354 was well tolerated and showed encouraging efficacy in pts with advanced GI cancers. Clinical development of IBI354 in these tumor types are ongoing. More data will be updated at the meeting."

Clinical • Metastases • P1 data • Biliary Cancer • Biliary Tract Cancer • Colorectal Cancer • Esophageal Cancer • Gastric Cancer • Gastroesophageal Junction Adenocarcinoma • Gastrointestinal Cancer • Oncology

Innovent Biologics (01801) IBI354 shows good efficacy in…advanced gynecological cancers [Google translation] (Zhitong Finance) - P1/2 | N=444 | NCT05636215 | Sponsor: Innovent Biologics (Suzhou) Co. Ltd. | "In this study, patients with HER2 IHC 1+, 2+ or 3+ advanced cervical cancer (CC), endometrial cancer (EC) or platinum-resistant ovarian cancer (OC) from China and Australia who failed or were intolerant to standard treatment received IBI354 treatment at doses of 6, 9 or 12 mg/kg Q3W, respectively...As of March 22, 2024, a total of 129 patients were enrolled, including 89 OC patients, 26 CC patients, and 14 EC patients. The median treatment duration was 12.3 weeks. The incidence of TRAEs was 81.4% (105 cases)..As of April 25, 2024, for patients who underwent at least one tumor assessment (n=124), the ORR was 39.5% and the DCR was 83.1%. The ORR for patients with ovarian cancer OC was 41.9% and the DCR was 81.4%; for 40 OC patients treated with a dose of 12 mg/kg, the ORR and DCR were 45.0% and 90.0%, respectively...The researchers believe that IBI354 is well tolerated and shows good efficacy..."

P1 data • Cervical Cancer • Endometrial Cancer • Gynecologic Cancers • Ovarian Cancer

IBI354 (anti-HER2 antibody-drug conjugate [ADC]) in patients (pts) with advanced solid tumors and breast cancer (BC): Results from a phase I study (ESMO 2024) - P1/2 | "Background: IBI354 is an ADC comprising trastuzumab (anti-HER2 antibody) conjugated to a topoisomerase I inhibitor. IBI354 was well tolerated, including at higher doses up to 12 mg/kg. Promising efficacy was observed in both HER2-positive and HER2-low BC."

Clinical • Metastases • P1 data • Breast Cancer • HER2 Breast Cancer • HER2 Positive Breast Cancer • Oncology • Solid Tumor

Innovent Delivers Oral Presentations on Clinical Data of IBI354 (HER2 Monoclonal Antibody-Camptothecin Derivative Conjugate) in Advanced Ovarian Cancer, Breast Cancer and Other Solid Tumors at the 2024 ESMO Congress (PRNewswire) - P1/2 | N=444 | NCT05636215 | Sponsor: Innovent Biologics (Suzhou) Co. Ltd. | "IBI354 monotherapy demonstrated excellent safety profile....The most common treatment-related adverse events (TRAEs) were nausea, decreased white blood cell count and anemia. The incidence of interstitial lung disease (ILD) was only 1.6%, all of which were grade 1. Overall, 21.5% of patients experienced TRAEs ≥ grade 3, 2.4% experienced TRAEs leading to dose reduction and 1.6% experienced TRAEs leading to discontinuation, with no TRAEs leading to death....In platinum-resistant ovarian cancer cohort (n=87, treated at 6~12mg/kg IBI354), the overall objective response rate (ORR) was 40.2% and the disease control rate (DCR) was 81.6%. In the 12mg/kg subgroup (n=40), the ORR reached 52.5% and the DCR was 90.0%....In HER2-positive breast cancer cohort (n= 59, treated at 6~15mg/kg IBI354), the ORR and DCR were 67.8% and 88.1%, respectively."

P1/2 data • Breast Cancer • Gynecologic Cancers • Ovarian Cancer • Solid Tumor

IBI354 (anti-HER2 antibody-drug conjugate [ADC]) in patients (pts) with advanced gynecological cancers (Gynecol C): Results from a phase I study (ESMO 2024) - P1/2 | "Background: IBI354 is an ADC consisting of trastuzumab (anti-HER2 antibody) conjugated to a topoisomerase I inhibitor. IBI354 was well tolerated and showed promising efficacy in pts with advanced Gynecol C. Clinical development of IBI354 in these tumors is ongoing. More data will be updated at the meeting."

Clinical • Metastases • P1 data • Cervical Cancer • Colorectal Cancer • Endometrial Cancer • Gynecologic Cancers • Oncology • Ovarian Cancer

Innovent Biologics (01801) IBI354 shows good efficacy in advanced solid tumors, breast cancer…[Google translation] (Zhitong Finance) - P1/2 | N=444 | NCT05636215 | Sponsor: Innovent Biologics (Suzhou) Co. Ltd. | "The study enrolled eligible patients who had failed or could not tolerate standard treatment. The dose of IBI354 was 0.8~15mg/kg, Q3W or Q2W. The dose expansion selected a dose level of ≥6mg/kg...As of March 22, 2024, a total of 318 patients were enrolled in China and Australia with ≥2 previous treatment regimens. The median treatment duration was 14.2 weeks, and 215 (67.6%) patients were still receiving treatment. No dose-limiting toxicity occurred at all dose levels...Effectiveness data showed that as of April 25, 2024, 44 patients with HER2-positive breast cancer underwent at least one tumor assessment, with an ORR of 61.4% and a DCR of 88.6%...The researchers believe that IBI354 is still well tolerated at higher doses up to 12 mg/kg, and good efficacy was observed in both HER2-positive and HER2-low breast cancers."

P1 data • Breast Cancer • HER2 Breast Cancer • HER2 Positive Breast Cancer • Solid Tumor

Innovent to Present Clinical Data of Multiple Novel Molecules at WCLC and ESMO 2024 (PRNewswire) - "Innovent Biologics...announces that nearly 20 accepted clinical data of its novel oncology molecules, including six oral presentations, will be released at World Conference on Lung Cancer (WCLC)...and the European Society of Medical Oncology (ESMO)....Key data showcase includes: an oral presentation of updated Phase 1 result of its first-in-class PD-1/IL-2α-bias (IBI363) in NSCLC (up to 3mg/kg dosage) at WCLC, updated Phase 1 results of IBI363 (PD-1/IL-2α-bias) combination therapy in colorectal cancer at ESMO, an oral presentation of updated pivotal Phase 2 results of Dupert (fulzerasib, KRAS G12C inhibitor) in NSCLC at WCLC, an oral presentation of Phase 1 results of IBI354 (HER2 ADC) in HER2+ solid tumors at ESMO, and multiple clinical results of TYVYT (sintilimab injection)."

Clinical data • P1 data • P2 data • Colorectal Cancer • Non Small Cell Lung Cancer

Innovent Biologics ' IBI354 clinical trial approved [Google translation] (new.qq.com) - "On August 2, according to the official website of CDE, Innovent Biologics' IBI354 clinical trial was approved and is intended to be used for platinum-resistant ovarian cancer, primary peritoneal cancer or fallopian tube cancer with HER2 expression (IHC 1+, 2+ or 3+)."

New trial • Fallopian Tube Cancer • Gynecologic Cancers • Oncology • Ovarian Cancer • Peritoneal Cancer • Solid Tumor • HER-2

A First-in-human Study of IBI354 in Subjects With Locally Advanced Unresectable or Metastatic Solid Tumors (clinicaltrials.gov) - P1/2 | N=444 | Not yet recruiting | Sponsor: Innovent Biologics (Suzhou) Co. Ltd.

New P1/2 trial • Oncology • Solid Tumor • HER-2