Phase 2 Study of SR-8541A in Combination With Botensilimab and Balstilimab in Subjects With Refractory Metastatic Microsatellite Stable Colorectal Cancer (MSS-CRC)

Conditions

• Refractory Metastatic Microsatellite Stable Colorectal Cancer (MSS-CRC)

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• SR-8541A — DRUG
  SR-8541A administered orally in combination with intravenous botensilimab and balstilimab

Study Details

This is an open-label, dose escalation and expansion, multi-center phase 2 study evaluating the safety and efficacy of SR-8541A administered orally in combination with intravenous botensilimab and balstilimab in subjects with MSS-CRC with and without active liver metastases.

Key Dates

Start date

Nov 20, 2024

Status verified

Jan 2026

Primary completion

Sep 30, 2027

Completion

Sep 30, 2027

Study Design

Enrollment

70 participants (estimated)

Allocation

NON_RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Experimental: MSS-CRC subject with no active liver metastases
• Experimental: MSS-CRC subject with active liver metastases

Primary Outcome Measure

To evaluate the safety, tolerability, efficacy, and define the optimal dose for expansion of SR-8541A in combination with botensilimab and balstilimab [ Time Frame: Approximately 3 dose levels (DL) will be investigated in 28-day cycles ]

Central Contacts

• Sunil Sharma, MD
  602-343-8402
  [email protected]
• Jonathan Northrup
  (317) 517-9500
  [email protected]

Locations (6)

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