Recent Updates
Recently added Catalysts

Ivonescimab Dose 1

Phase 2

Metastatic Urothelial Carcinoma | Small molecule | Oncology |Summit Therapeutics Inc.|Last Updated: Sep 11, 2026

Target and mechanism

Target class-Mab (Antibody)
ModalitySmall molecule

Also known as ivonescimab, Ivonescimab, Ivonescimab Injection, Drug: Ivonescimab Injection, Drug: Ivonescimab

Success Probability

Subscribe to view

Market & Valuation

Subscribe to view

Trial Design

RandomizedACTIVE_CONTROLLEDDMC
Total Trials1
Total Enrollment800

FDA Designations

No designations recorded

Clinical trial landscape

Ivonescimab Dose 1 · 1 trial · 2 indications

Phase 2 1
NCT07815665A Study of Ivonescimab in Combination With Enfortumab Vedotin vs Pembrolizumab in Combination With Enfortumab Vedotin in Metastatic Urothelial CarcinomaMetastatic Urothelial Carcinoma
RECRUITING800 Analytics
PHASE2RECRUITING
A Study of Ivonescimab in Combination With Enfortumab Vedotin vs Pembrolizumab in Combination With Enfortumab Vedotin in Metastatic Urothelial Carcinoma
Metastatic Urothelial Carcinoma
NCT07815665800
Unlock trial analytics

Study Endpoints

Primary Endpoints

Phase 2 Primary Outcome Measure
Through 90 days after the last study treatment

Adverse events (AEs) as characterized by type, incidence, severity, seriousness, and relationship to study treatment

Phase 3 Primary Outcome Measure
From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 3 years.

PFS per RECIST v1.1 by Independent Radiology Review Committee (IRRC)

Secondary Endpoints

Phase 2 Secondary Outcome Measure
From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 3 years
Phase 3 Secondary Outcome Measure
From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 3 years
Unlock Study Endpoints

Study Design & Arms

AllocationRANDOMIZED
MaskingNONE
ModelPARALLEL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
Phase 2: Arm AEXPERIMENTALIvonescimab Dose 1 + EV
Phase 2: Arm BEXPERIMENTALIvonescimab Dose 2 + EV
Phase 3: Arm 1EXPERIMENTALIvonescimab RP3D (recommended Phase 3 dose) + EV
Phase 3: Arm 2ACTIVE_COMPARATORPembrolizumab 200 mg + EV

Interventions

NameTypeDescription
Ivonescimab Dose 1DRUGFirst ivonescimab dose to be tested in Phase 2
enfortumab vedotin (EV)DRUGStandard of care therapy
PembrolizumabDRUG200 mg
Ivonescimab Dose 2DRUGSecond Ivonescimab dose to be tested in Phase 2 part of the study
Ivonescimab RP3DDRUGRecommended Phase 3 dose of Ivonescimab after Phase 2 data analysis
Unlock Study Design Details

Eligibility Criteria

Age Range18 Years to N/A
SexALL
Healthy VolunteersNo
Study Sites7

Inclusion Criteria: * 18 years and older * ECOG 0-1 * Life expectancy ≥ 6 months * Histologically documented unresectable LA/mUC (transitional cell carcinoma) of the bladder, renal pelvis, ureter, or urethra with ≥50% urothelial carcinoma component * No prior systemic therapy for LA/mUC * At least ...

Countries:United States
Unlock Eligibility Criteria

Recent Changes (Last 90 Days)

LOWSep 11, 2026NCT07815665NEW_TRIAL: changed
LOWSep 11, 2026NCT07815665NEW_TRIAL: changed

Frequently asked questions about Ivonescimab Dose 1

What is Ivonescimab?

Ivonescimab is an investigational oncology therapy being developed by Summit Therapeutics Inc. (SMMT). It is a small molecule in the antibody class and is being studied in multiple cancer types, including non-small cell lung cancer, small cell lung cancer, colorectal cancer, esophageal adenocarcinoma, biliary tract cancer, and other solid tumors. It remains in clinical development and is not approved.

What is Ivonescimab used for?

Ivonescimab is being studied for several cancer indications, including non-small cell lung cancer, extensive stage small cell lung cancer, metastatic colorectal cancer, metastatic esophageal adenocarcinoma, and biliary tract cancer. Additional Phase 2 studies are evaluating it in appendiceal adenocarcinoma, adrenocortical carcinoma, pheochromocytoma, and paraganglioma. It is investigational and not approved for any use.

Who makes Ivonescimab?

Ivonescimab is being developed by Summit Therapeutics Inc., which trades under the ticker SMMT. The company is running Phase 2 and Phase 3 clinical trials of the agent across multiple solid tumor types, including lung, colorectal, head and neck, and rare cancers.

What phase is Ivonescimab in?

Ivonescimab is in Phase 2 and Phase 3 clinical development. It is an investigational agent and has not been approved by the FDA. The program includes active-controlled, randomized trials, with a total enrollment across studies of approximately 2,380 patients and biomarker-selected patient populations.

What clinical trials is Ivonescimab in?

Ivonescimab is being tested in trials including NCT07753824 in high-grade metastatic appendiceal adenocarcinoma, NCT07743138 in adrenocortical carcinoma or pheochromocytoma/paraganglioma, NCT07359456 in metastatic colorectal cancer without liver metastases, and NCT07264075, a Phase 3 study in squamous cell carcinoma of the head and neck.

Is Ivonescimab the same as Ivonescimab Injection?

Yes. Ivonescimab is also referred to as Ivonescimab Injection, Ivonescimab 10 mg/kg, Ivonescimab/kg, and Ivonescimab Dose 1. These names refer to the same investigational agent developed by Summit Therapeutics Inc. (SMMT) and do not indicate separate products.