ubamatamab (REGN4018) / Regeneron - LARVOL DELTA

Ubamatamab (REGN4018, MUC16xCD3 bispecific antibody) monotherapy in patients with recurrent ovarian cancer (OC): Phase I dose-escalation analysis (ESMO 2022) - P1/2 | "Conclusions Ubamatamab safety profile was acceptable with evidence of durable responses in this heavily pretreated population with OC across a wide dose range. Based on data from this study, a randomised Phase 2 expansion has been initiated."

Clinical • Monotherapy • P1 data • Oncology • Ovarian Cancer • Solid Tumor • MUC16

PHASE 2 STUDY OF UBAMATAMAB ALONE OR IN COMBINATION WITH ADDITIONAL AGENTS IN PATIENTS WITH PLATINUM-RESISTANT OVARIAN CANCER: TRIAL IN PROGRESS (IGCS 2026) - P2 | "Combination arms include ubamatamab + standard doses of bevacizumab (Arm B), triple immunotherapy (ubamatamab + cemiplimab + fianlimab; Arm C), and ubamatamab + pegylated liposomal doxorubicin (Arm D). Patients will receive sarilumab prophylaxis to mitigate CRS risk...Primary completion is December 2028. With limited immunotherapy options in PROC, ubamatamab may offer a novel approach."

Clinical • Combination therapy • P2 data • Platinum resistant • Oncology • Ovarian Cancer • Solid Tumor

Circulating tumour DNA (ctDNA), cancer antigen 125 (CA125) and human epididymis protein 4 (HE4) associate with survival outcomes in patients with platinum-resistant ovarian cancer (PROC) treated with ubamatamab (uba) (ESMO 2026) - No abstract available

Circulating tumor DNA • Clinical • Platinum resistant • Oncology • Ovarian Cancer • Solid Tumor

Phase II Trial of Ubamatamab in MUC16-Expressing SMARCB1-Deficient Renal Medullary Carcinoma and Epithelioid Sarcoma (KCRS 2024) - "As proof of concept, a 20-year-old patient with metastatic SMARCB1-negative ES expressing high levels of serum CA125 achieved a durable (12+ months) partial response to ubamatamab after progressing on multiple prior therapies, including EZH2 inhibition with tazemetostat as well as antiPD1/CTLA4 immune checkpoint inhibition with nivolumab plus ipilimumab...Patients with disease progression on ubamatamab monotherapy during Stage I can proceed to stage II, which will evaluate the combination of ubamatamab with cemiplimab combination...Mucin 16 (cancer antigen 125) Expression in Epithelioid Sarcoma leads to Single-Patient Study with Bispecific T-Cell Engager Ubamatamab (Mucin16xCD3): A Bench-ToBedside Experience. Connective Tissue Oncology Society, Nov 16–19, 2022, Vancouver, Canada."

IO biomarker • P2 data • Cardiovascular • Kidney Medullary Carcinoma • Oncology • Ovarian Cancer • Renal Cell Carcinoma • Respiratory Diseases • Sarcoma • Soft Tissue Sarcoma • Solid Tumor • MUC16 • SMARCB1

R5668-ONC-1938: A Study to Find Out How Safe REGN5668 is and How Well it Works In Adult Women When Given With Either Cemiplimab, or Cemiplimab + Fianlimab, or Ubamatamab (clinicaltrials.gov) - P1/2 | N=612 | Recruiting | Sponsor: Regeneron Pharmaceuticals | Trial completion date: Nov 2027 ➔ Nov 2028 | Trial primary completion date: Mar 2027 ➔ Nov 2028

Trial completion date • Trial primary completion date • Endometrial Cancer • Fallopian Tube Cancer • Oncology • Ovarian Cancer • Peritoneal Cancer • Solid Tumor

Investigation of Ubamatamab Combination Therapy in Adult Participants With Platinum-Resistant Ovarian Cancer (clinicaltrials.gov) - P2 | N=297 | Recruiting | Sponsor: Regeneron Pharmaceuticals | N=220 ➔ 297 | Trial completion date: Oct 2028 ➔ Jun 2028 | Trial primary completion date: Oct 2028 ➔ Jun 2028

Enrollment change • Platinum resistant • Trial completion date • Trial primary completion date • Fallopian Tube Cancer • Oncology • Ovarian Cancer • Peritoneal Cancer • Solid Tumor

Phase II Trial of Ubamatamab Alone or in Combination With Cemiplimab in MUC16-Expressing SMARCB1-Deficient Malignancies (clinicaltrials.gov) - P2 | N=15 | Active, not recruiting | Sponsor: M.D. Anderson Cancer Center | Recruiting ➔ Active, not recruiting | N=40 ➔ 15 | Trial primary completion date: Jul 2028 ➔ Jul 2027

Enrollment change • Enrollment closed • Trial primary completion date • Kidney Medullary Carcinoma • Oncology • Renal Cell Carcinoma • Sarcoma • Soft Tissue Sarcoma • Solid Tumor • MUC16 • SMARCB1

A phase 1/2 study of REGN5668, a MUC16×CD28 costimulatory bispecific antibody, in combination with other targeted therapies, in patients with recurrent ovarian or endometrial cancer: Trial in progress update. (ASCO 2026) - P1/2 | "This first-in-human, multicenter, Phase 1/2 trial (NCT04590326) will assess safety, tolerability, pharmacokinetics (PK), and antitumor activity of REGN5668 + cemiplimab ± fianlimab (Module 1) or ubamatamab (Module 2) in patients with platinum-resistant recurrent ovarian cancer (OC) or endometrial cancer (EC)...Patients may also receive sarilumab to mitigate the risk of cytokine release syndrome...Module 1 dose expansion has opened, with the first two patients enrolled. In Module 2, dose escalation of REGN5668 has progressed through multiple dose levels; enrollment is ongoing."

Bispecific • Clinical • Combination therapy • First-in-human • P1/2 data • Carcinosarcoma • Dry Eye Disease • Endometrial Cancer • Oncology • Ophthalmology • Ovarian Cancer • Sarcoma • Solid Tumor • MUC16

R4018-ONC-1721: Study of REGN4018 (Ubamatamab) Administered Alone or in Combination With Cemiplimab in Adult Patients With Recurrent Ovarian Cancer or Other Recurrent Mucin-16 Expressing (MUC16+) Cancers (clinicaltrials.gov) - P1/2 | N=890 | Recruiting | Sponsor: Regeneron Pharmaceuticals | Trial completion date: Jan 2027 ➔ May 2027 | Trial primary completion date: Feb 2026 ➔ May 2027

Platinum resistant • Trial completion date • Trial primary completion date • Endometrial Cancer • Fallopian Tube Cancer • Oncology • Ovarian Cancer • Ovarian Serous Adenocarcinoma • Peritoneal Cancer • Solid Tumor • MUC16

A phase 1/2 study of ubamatamab (REGN4018), a MUC16×CD3 bispecific antibody, administered alone or in combination with cemiplimab in a low-grade serous ovarian cancer cohort: Trial in progress. (ASCO 2026) - P1/2 | "Prior to Q3W dosing of ubamatamab, patients will receive once-weekly step-up dosing to mitigate the risk of cytokine release syndrome, as well as sarilumab 350 mg IV prophylaxis on Day 1. As of January 5, 2026, 6 patients with LGSOC have initiated ubamatamab treatment. Findings from this study will clarify the therapeutic potential of targeting MUC16 in LGSOC."

Bispecific • Combination therapy • First-in-human • P1/2 data • Oncology • Ovarian Cancer • Ovarian Serous Adenocarcinoma • Solid Tumor • MUC16

RegeNovar: Safety and Efficacy of Ubamatamab With First-line Chemotherapy in Ovarian Cancer (clinicaltrials.gov) - P1/2 | N=43 | Not yet recruiting | Sponsor: ARCAGY/ GINECO GROUP

New P1/2 trial • Oncology • Ovarian Cancer • Solid Tumor • BRCA • CD4 • HRD • MUC16

RegeNovar: A phase I/II study of ubamatamab plus carboplatin, paclitaxel, and bevacizumab as salvage therapy in ovarian cancer with poor response to first-line chemotherapy. (ASCO 2026) - "Subsequent maintenance treatment consists of olaparib plus bevacizumab for patients with BRCA-mutated or HRD-positive tumors, or ubamatamab plus bevacizumab for up to 15 months in patients with HRD-negative tumors. Secondary endpoints include ORR, duration of response, disease control rate, rate of late cytoreductive surgery, PFS, OS, and progression-free survival during subsequent therapy. The trial is sponsored by ARCAGY-GINECO, conducted in 12 French centers, and funded by Regeneron."

Clinical • P1/2 data • Epithelial Ovarian Cancer • Oncology • Ovarian Cancer • Solid Tumor • BRCA • MUC16

Gineco-ov133b: REGENOVAR: A Phase I/II Study of Ubamatamab Plus Carboplatin, Paclitaxel, and Bevacizumab as Salvage Therapy in Ovarian Cancer with Poor Response to First-Line Chemotherapy. (clinicaltrialsregister.eu) - P1/2 | N=43 | Not yet recruiting | Sponsor: Asso De Recherche Cancers Gynecologiques

New P1/2 trial • Oncology • Ovarian Cancer • Solid Tumor • BRCA • HRD

Ex vivo micro-tumor testing platform to characterize and predict patient-specific immunotherapy drug responses (AACR 2026) - "Micro-tumors including the TME were isolated from resections, ascites or pleural fluid, embedded in hydrogel and exposed to chemotherapeutics, six ICIs and/or CD3xMUC16 BiTE ubamatamab...Our ex vivo micro-tumor platform enables functional profiling of patient-specific immunotherapy responses, supporting biomarker discovery and selection of patients for emerging immunotherapies. The next step is to correlate the ex vivo sensitivity to actual clinical outcome."

IO biomarker • Preclinical • Colorectal Cancer • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Ovarian Cancer • Solid Tumor • CD68 • CXCL11 • CXCL9 • GZMB • IFNG • IL2

Compassionate Use of Ubamatamab (clinicaltrials.gov) - P=N/A | N=0 | Available | Sponsor: Regeneron Pharmaceuticals

New trial • Kidney Medullary Carcinoma • Oncology • Renal Cell Carcinoma • Sarcoma • Soft Tissue Sarcoma • Solid Tumor

A Study to Investigate Ubamatamab With and Without REGN7075 in Adult Participants With Advanced/Metastatic Non-Small Cell Lung Cancer (NSCLC) (clinicaltrials.gov) - P2 | N=300 | Recruiting | Sponsor: Regeneron Pharmaceuticals | Not yet recruiting ➔ Recruiting

Enrollment open • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor • MUC16

A Phase 2 study of ubamatamab (REGN4018), a MUC16×CD3 bispecific antibody, administered alone or in combination with additional agents in patients with platinum-resistant ovarian cancer: Trial in progress (SGO 2026) - No abstract available

Bispecific • Clinical • Combination therapy • P2 data • Platinum resistant • Oncology • Ovarian Cancer • Solid Tumor

R4018-ONC-1721: Study of REGN4018 (Ubamatamab) Administered Alone or in Combination With Cemiplimab in Adult Patients With Recurrent Ovarian Cancer or Other Recurrent Mucin-16 Expressing (MUC16+) Cancers (clinicaltrials.gov) - P1/2 | N=554 | Recruiting | Sponsor: Regeneron Pharmaceuticals | N=404 ➔ 554 | Trial primary completion date: Dec 2023 ➔ Jul 2024

Enrollment change • Trial primary completion date • Endometrial Cancer • Fallopian Tube Cancer • Oncology • Ovarian Cancer • Ovarian Serous Adenocarcinoma • Peritoneal Cancer • Solid Tumor

R4018-ONC-1721: Study of REGN4018 (Ubamatamab) Administered Alone or in Combination With Cemiplimab in Adult Patients With Recurrent Ovarian Cancer or Other Recurrent Mucin-16 Expressing (MUC16+) Cancers (clinicaltrials.gov) - P1/2 | N=392 | Recruiting | Sponsor: Regeneron Pharmaceuticals | Trial completion date: Mar 2023 ➔ Jan 2024 | Trial primary completion date: May 2022 ➔ Mar 2023

Trial completion date • Trial primary completion date • Endometrial Cancer • Fallopian Tube Cancer • Oncology • Ovarian Cancer • Ovarian Serous Adenocarcinoma • Peritoneal Cancer • Solid Tumor

R4018-ONC-1721: Study of REGN4018 (Ubamatamab) Administered Alone or in Combination With Cemiplimab in Adult Patients With Recurrent Ovarian Cancer or Other Recurrent Mucin-16 Expressing (MUC16+) Cancers (clinicaltrials.gov) - P1/2 | N=366 | Recruiting | Sponsor: Regeneron Pharmaceuticals | N=264 ➔ 366 | Trial completion date: May 2022 ➔ Mar 2023

Enrollment change • Trial completion date • Endometrial Cancer • Fallopian Tube Cancer • Gynecologic Cancers • Oncology • Ovarian Cancer • Ovarian Serous Adenocarcinoma • Peritoneal Cancer • Solid Tumor

R4018-ONC-1721: Study of REGN4018 (Ubamatamab) Administered Alone or in Combination With Cemiplimab in Adult Patients With Recurrent Ovarian Cancer or Other Recurrent Mucin-16 Expressing (MUC16+) Cancers (clinicaltrials.gov) - P1/2 | N=264 | Recruiting | Sponsor: Regeneron Pharmaceuticals

New P1/2 trial • Endometrial Cancer • Fallopian Tube Cancer • Gynecologic Cancers • Oncology • Ovarian Cancer • Ovarian Serous Adenocarcinoma • Peritoneal Cancer • Solid Tumor

R4018-ONC-1721: Study of REGN4018 (Ubamatamab) Administered Alone or in Combination With Cemiplimab in Adult Patients With Recurrent Ovarian Cancer or Other Recurrent Mucin-16 Expressing (MUC16+) Cancers (clinicaltrials.gov) - P1/2 | N=690 | Recruiting | Sponsor: Regeneron Pharmaceuticals | Trial completion date: Jul 2024 ➔ Jun 2026 | Trial primary completion date: Jul 2024 ➔ Jun 2026

Trial completion date • Trial primary completion date • Endometrial Cancer • Fallopian Tube Cancer • Oncology • Ovarian Cancer • Ovarian Serous Adenocarcinoma • Peritoneal Cancer • Solid Tumor

A phase 1/2 study of ubamatamab (REGN4018): low-grade serous ovarian cancer expansion cohort (ESGO 2026) - P1/2 | "Sarilumab, an anti–interleukin-6 receptor α-subunit monoclonal antibody, is being evaluated for mitigation of ubamatamab-associated cytokine release syndrome (CRS). Results As of April 2025, 19 patients with LGSOC have been treated; initial data analysis is expected by March 2027. Conclusion Insights into the efficacy and safety of ubamatamab in patients with LGSOC may further validate MUC16 as a novel therapeutic target for LGSOC."

P1/2 data • Oncology • Ovarian Cancer • Ovarian Serous Adenocarcinoma • Solid Tumor • IL6R • MUC16

A phase 1/2 trial investigating REGN5668, a MUC16×CD28 costimulatory bispecific antibody, in combination with other targeted therapies in patients with recurrent ovarian or endometrial cancer: trial in progress update (ESGO 2026) - P1/2 | "In stage 1, 20 patients will be enrolled; if there are ≥3/20 objective responses, ≤50 patients will be enrolled in stage 2.Module 2 dose-escalation will evaluate REGN5668 + ubamatamab (± sarilumab [anti–interleukin-6 receptor α-subunit monoclonal antibody]) in an OC cohort using a Bayesian optimal interval design. Key secondary endpoints: ORR (Module 2 dose-escalation), safety and pharmacokinetics (Module 1 dose-expansion), further efficacy outcomes, immunogenicity.Results Module 1 dose-expansion has enrolled the first patient. Module 2 dose-escalation has progressed through multiple dose levels (enrolment ongoing).Conclusion This trial will evaluate REGN5668 + cemiplimab ± fianlimab or + ubamatamab in patients with OC/EC."

Clinical • Combination therapy • First-in-human • P1/2 data • Carcinosarcoma • Endometrial Cancer • Oncology • Ovarian Cancer • Sarcoma • Solid Tumor • IL6R • MUC16

R4018-ONC-1721: Study of REGN4018 (Ubamatamab) Administered Alone or in Combination With Cemiplimab in Adult Patients With Recurrent Ovarian Cancer or Other Recurrent Mucin-16 Expressing (MUC16+) Cancers (clinicaltrials.gov) - P1/2 | N=404 | Recruiting | Sponsor: Regeneron Pharmaceuticals | Trial completion date: Jan 2024 ➔ Jun 2024 | Trial primary completion date: Mar 2023 ➔ Dec 2023

Trial completion date • Trial primary completion date • Endometrial Cancer • Fallopian Tube Cancer • Oncology • Ovarian Cancer • Ovarian Serous Adenocarcinoma • Peritoneal Cancer • Solid Tumor