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RO7836748

Phase 1

Solid Tumors | Small molecule | Oncology |Roche Holding AG|Trials Updated: Oct 30, 2026

RO7836748 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

RandomizedCONTROLLEDBiomarker
Total Trials1
Total Enrollment540

FDA Designations

No designations recorded

RO7836748 clinical trials

RO7836748 · 1 trial · 1 indication

Phase 1 1
NCT07905924A Study to Evaluate the Safety and Effectiveness of Different Doses of RO7836748 Alone or in Combination With Other Cancer Therapies in People With Solid Tumors With a Rat Sarcoma Viral Oncogene Homolog Glycine 12 Valine (RAS G12V) MutationSolid Tumors
NOT YET_RECRUITING540 Analytics
PHASE1NOT YET_RECRUITING
A Study to Evaluate the Safety and Effectiveness of Different Doses of RO7836748 Alone or in Combination With Other Cancer Therapies in People With Solid Tumors With a Rat Sarcoma Viral Oncogene Homolog Glycine 12 Valine (RAS G12V) Mutation
Solid Tumors
NCT07905924540
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Study Endpoints

Primary Endpoints

Parts 1A and 1B: Incidence and Severity of Adverse Events (AEs)
From first dose up to approximately 5 years
Part 2: Incidence and Severity of AEs
From first dose up to approximately 5 years
Parts 3A, 3B and 3C: Incidence and Severity of AEs
From first dose up to approximately 5 years
Parts 1A and 1B: Incidence of Dose-limiting Toxicities (DLTs)
From Cycle 1 Day 1 (C1D1) until C1D21 (Cycle 1 = 21 days)
Part 3A: Incidence of DLTs
From C1D1 until C1D21 (Cycle 1 = 21 days)
Parts 3B and 3C: Incidence of DLTs
From C1D1 until C1D28 (Cycle 1 = 28 days)
Parts 1A and 1B: Recommended Dose for Expansion (RDE) of RO7836748 Monotherapy
Up to approximately 5 years
Parts 3A, 3B, 3C: RDE of RO7836748 in Combination With Other Anti-Cancer Therapies
Up to approximately 5 years

Secondary Endpoints

Parts 1A, 1B and 2: Plasma Concentrations of RO7836748 and its Metabolites as Monotherapy
Up to approximately 5 years
Parts 3A, 3B and 3C: Plasma Concentrations of RO7836748 and its Metabolites in Combination With Other Anti-Cancer Therapies.
Up to approximately 5 years
All Parts: Objective response rate (ORR)
Up to approximately 5 years
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Study Design & Arms

AllocationRANDOMIZED
MaskingNONE
ModelSEQUENTIAL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
Part 1A: RO7836748 Monotherapy (Dose Escalation)EXPERIMENTALParticipants with advanced solid tumors (second line or higher \[2L+\]) with a RAS G12V mutation will receive increasing doses of RO7836748.
Part 1B: RO7836748 Monotherapy Backfill CohortsEXPERIMENTALParticipants with (2L+) NSCLC, PDAC, and CRC with a RAS G12V mutation will receive the selected doses of RO7836748 at sponsor's discretion Some participants enrolled may also participate in a food effect assessment and/or a drug-drug interaction (DDI) investigation, if necessary.
Part 2: RO7836748 Monotherapy (Dose Expansion)EXPERIMENTALParticipants with 2L+ NSCLC, PDAC, and CRC with a RAS G12V mutation will receive RO7836748 at the dose selected based on findings from Part 1A and 1B.
Part 3A: RO7836748 + Pembrolizumab (Dose Escalation and Randomized Expansion)EXPERIMENTALParticipants with untreated advanced (first line treatment \[1L+\]) or metastatic NSCLC with a KRAS G12V mutation and programmed death-ligand (PD-Ll ) tumor cell expression levels ≥ 1% will receive RO7836748 in combination with pembrolizumab at the dose selected based on findings from Parts 1 and 2.
Part 3B: RO7836748 + mFOLFIRINOX (Dose Escalation and Randomized Expansion)EXPERIMENTALParticipants with untreated advanced (1L) or metastatic PDAC will receive RO7836748 in combination with mFOLFIRINOX at the dose selected based on findings from Parts 1 and 2.
Part 3C: RO7836748 + Cetuximab (Dose Escalation and Randomized Expansion)EXPERIMENTALParticipants with CRC after second line/ third line (2L/3L) treatment will receive RO7836748 in combination with cetuximab at the dose selected based on findings from Parts 1 and 2.

Interventions

NameTypeDescription
RO7836748DRUGParticipants will receive RO7836748 as per the schedule described in the protocol.
PembrolizumabDRUGParticipants will receive pembrolizumab as per the schedule described in the protocol.
mFOLFIRINOXDRUGParticipants will receive mFOLFIRINOX as per the schedule described in the protocol.
CetuximabDRUGParticipants will receive cetuximab 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: * Participants with measurable disease according to Response Evaluation Criteria in Solid Tumors (RECIST) version (v)1.1 assessed by the Investigator * Previously irradiated lesions can be considered as measurable disease only if progressive disease has been unequivocally docume...

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Competitive Landscape -Other Solid Tumors 10 trials (matched to "Solid Tumors")

CompanyTickerTrialsLead PhaseDrugs
Merck & Co., Inc.MRK3PHASE2Pembrolizumab, Gardasil 9
Incyte CorporationINCY1PHASE2Retifanlimab
Novartis AG Sponsored ADRNVS1PHASE1KFA115
Iovance Biotherapeutics IncIOVA2PHASE2Aldesleukin
AstraZeneca PLCAZN1 - Trastuzumab deruxtecan
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Recent Changes (Last 90 Days)

LOWOct 30, 2026NCT07905924NEW_TRIAL: changed
LOWOct 30, 2026NCT07905924NEW_TRIAL: changed

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