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RO7821657

Phase 1

Locally Advanced or Metastatic Solid Tumors | Small molecule | Oncology |Roche Holding AG|Trials Updated: Oct 20, 2026

RO7821657 development status

Highest phase Phase 1
Registered trials 1 across 1 sponsor since Oct 2026

Success Probability

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Market & Valuation

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Trial Design

CONTROLLED
Total Trials1
Total Enrollment405

FDA Designations

No designations recorded

RO7821657 clinical trials

RO7821657 · 1 trial · 1 indication

Phase 1 1
NCT07883577A Study of RO7821657 in Participants With Solid TumorsLocally Advanced or Metastatic Solid Tumors
NOT YET_RECRUITING405 Analytics
PHASE1NOT YET_RECRUITING
A Study of RO7821657 in Participants With Solid Tumors
Locally Advanced or Metastatic Solid TumorsUnlock trial analytics

Study Endpoints

Primary Endpoints

Part 1: Incidence and Severity of Adverse Events (AEs)
Up to approximately 27 months

AEs will be graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 5.0. Any events of cytokine release syndrome (CRS) and immune effector cell-associated neurotoxicity syndrome (ICANS) will be graded based on the American Society for Transplantation and Cellular Therapy (ASTCT) criteria

Part 2: Incidence and Severity of Adverse Events (AEs)
Up to approximately 27 months

AEs will be graded according to NCI CTCAE v5.0. Any events of CRS and ICANS will be graded based on the ASTCT criteria

Part 1A: Nature and Frequency of Dose-limiting Toxicities (DLTs)
From Cycle 1 (C1) Day 1 to the last day in C1 (Cycle 1 = 14-35 days)
Part 2A: Nature and Frequency of DLTs
From C1 Day 1 to the last day in C1 (Cycle 1 = 14-35 days)
Parts 1A and 1B: Recommended Phase 2 Dose (RP2D) Range of RO7821657
Up to approximately 27 months
Part 2A: RP2D Range of RO7821657
Up to approximately 27 months

Secondary Endpoints

Parts 1 and 2: Serum Concentration of RO7821657
Up to approximately 27 months
Parts 1 and 2: Objective Response Rate (ORR)
Up to approximately 27 months
Parts 1 and 2: Disease Control Rate (DCR)
Up to approximately 27 months
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Study Design & Arms

AllocationNON_RANDOMIZED
MaskingNONE
ModelSEQUENTIAL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
Part 1A: Dose EscalationEXPERIMENTALParticipants with MSS CRC will receive multiple doses of RO7821657 in single and multiple participant cohorts.
Part 1B: Backfill CohortsEXPERIMENTALParticipants with MSS CRC will receive RO7821657 at dosing regimen selected based on data from Part 1A.
Part 1C: Dose Expansion/OptimizationEXPERIMENTALParticipants with MSS CRC will receive RO7821657 at dosing regimens selected based on data from Parts 1A and 1B.
Part 2A: Abbreviated Dose EscalationEXPERIMENTALParticipants with non-squamous NSCLC will receive multiple doses of RO7821657 in multiple participant cohorts.
Part 2B: Dose Expansion/OptimizationEXPERIMENTALParticipants with non-squamous NSCLC will receive RO7821657 at dosing regimen selected based on data from Part 2A.

Interventions

NameTypeDescription
RO7821657DRUGParticipants will receive RO7821657 as per the schedule described in the protocol.
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Eligibility Criteria

Age Range18 Years to N/A
SexALL
Healthy VolunteersNo

Inclusion Criteria: * Life expectancy estimated by the Investigator to be ≥12 weeks. * Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) 0-1. * Presence of measurable disease according to Response Evaluation Criteria in Solid Tumors (RECIST) v1.1; previously irradiated lesions are c...

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Recent Changes (Last 90 Days)

LOWOct 20, 2026NCT07883577NEW_TRIAL: changed
LOWOct 20, 2026NCT07883577NEW_TRIAL: changed