AzTrials
AzTrials

Solid TumorsPhase 1NCT07905924

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

A Phase 1 study testing RO7836748, Pembrolizumab and mFOLFIRINOX in people with Solid Tumors, run by Hoffmann-La Roche.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts
Official record
Search all trials

Trial summary

The study will evaluate the safety, tolerability, pharmacokinetics (PK), pharmacodynamics (PD), and preliminary clinical activity of RO7836748 as monotherapy and in combination with other anti-cancer therapies, including cetuximab, pembrolizumab, or modified (m)FOLFIRINOX in participants with Kirsten rat sarcoma viral… Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Solid Tumors
What is being tested?
RO7836748, Pembrolizumab and mFOLFIRINOX
Could I receive a placebo?
No, everyone receives an active treatment
How many people
540 participants
Where
No sites listed yet
Study dates
31 Dec 2026to 30 Mar 2032
Phase
Phase 1
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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 documented at that site since radiation
  • Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1
  • Adequate hematologic and end-organ function
  • Life expectancy ≥12 weeks, as determined by the Investigator
  • Presence of KRAS, neuroblastoma RAS viral oncogene homolog (NRAS) or Harvey rat sarcoma viral oncogene homolog (HRAS) G12V mutation in blood or tumor tissue previously determined by a local assay at any time prior to Screening
  • Consent to provide archival tumor tissue, if available

Who cannot join

  • Known hypersensitivity or medical contraindication to any component of the RO7836748 formulation
  • Inability or unwillingness to swallow pills
  • Refractory nausea and vomiting, malabsorption, external biliary shunt, or significant small bowel resection that would preclude adequate study treatment absorption
  • Inability to comply with study and follow-up procedures
  • Participants with chronic diarrhea, short bowel syndrome or significant upper GI surgery including gastric resection, a history of inflammatory bowel disease (e.g., Crohn's disease or ulcerative colitis) or any active bowel inflammation (including, but not limited to, peptic ulcer disease, and diverticulitis).
  • Known and untreated or active central nervous system (CNS) metastases (progressing or requiring anticonvulsants or corticosteroids for symptomatic control)
  • Participants with any leptomeningeal disease

Trial locations and contacts

No sites are listed yet. Contact the study team or a site near you to ask about taking part.

Reference Study ID Number: BP46856 https://forpatients.roche.com/ No attachments to email below. contact

888-662-6728 (U.S. and Canada)

global-roche-genentech-trials@gene.com

Fastest response: use the inquiry form. https://www.gene.com/contact-us/submit-medical-inquiry contact

About this study

Official title: A Phase I Dose Escalation and Expansion Study to Evaluate the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Preliminary Clinical Activity of RO7836748 as Monotherapy and in Combination With Other Anti-Cancer Therapies in Participants With Advanced Solid Tumors With a RAS G12V Mutation

The study will evaluate the safety, tolerability, pharmacokinetics (PK), pharmacodynamics (PD), and preliminary clinical activity of RO7836748 as monotherapy and in combination with other anti-cancer therapies, including cetuximab, pembrolizumab, or modified (m)FOLFIRINOX in participants with Kirsten rat sarcoma viral oncogene homolog (KRAS) G12V-positive solid tumors such as non-small cell lung cancer (NSCLC), pancreatic ductal adenocarcinoma (PDAC), and colorectal cancer (CRC), and other solid tumors.

Conditions
Solid Tumors
Being tested
RO7836748, Pembrolizumab, mFOLFIRINOX, Cetuximab

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • RO7836748Drug

    Participants will receive RO7836748 as per the schedule described in the protocol.

  • PembrolizumabDrug

    Participants will receive pembrolizumab as per the schedule described in the protocol.

  • mFOLFIRINOXDrug

    Participants will receive mFOLFIRINOX as per the schedule described in the protocol.

  • CetuximabDrug

    Participants will receive cetuximab as per the schedule described in the protocol.

Study groups in NCT07905924
Study groupRoleWhat they receive
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.
Receives: Drug: 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.
Receives: Drug: RO7836748
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.
Receives: Drug: RO7836748
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.
Receives: Drug: RO7836748; Drug: Pembrolizumab
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.
Receives: Drug: RO7836748; Drug: mFOLFIRINOX
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.
Receives: Drug: RO7836748; Drug: Cetuximab

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Parts 1A and 1B: Incidence and Severity of Adverse Events (AEs)

    Measured: From first dose up to approximately 5 years

  2. Part 2: Incidence and Severity of AEs

    Measured: From first dose up to approximately 5 years

  3. Parts 3A, 3B and 3C: Incidence and Severity of AEs

    Measured: From first dose up to approximately 5 years

  4. Parts 1A and 1B: Incidence of Dose-limiting Toxicities (DLTs)

    Measured: From Cycle 1 Day 1 (C1D1) until C1D21 (Cycle 1 = 21 days)

  5. Part 3A: Incidence of DLTs

    Measured: From C1D1 until C1D21 (Cycle 1 = 21 days)

  6. Parts 3B and 3C: Incidence of DLTs

    Measured: From C1D1 until C1D28 (Cycle 1 = 28 days)

  7. Parts 1A and 1B: Recommended Dose for Expansion (RDE) of RO7836748 Monotherapy

    Measured: Up to approximately 5 years

  8. Parts 3A, 3B, 3C: RDE of RO7836748 in Combination With Other Anti-Cancer Therapies

    Measured: Up to approximately 5 years

Secondary outcomes (7)

  1. Parts 1A, 1B and 2: Plasma Concentrations of RO7836748 and its Metabolites as Monotherapy

    Measured: Up to approximately 5 years

  2. Parts 3A, 3B and 3C: Plasma Concentrations of RO7836748 and its Metabolites in Combination With Other Anti-Cancer Therapies.

    Measured: Up to approximately 5 years

  3. All Parts: Objective response rate (ORR)

    Measured: Up to approximately 5 years

  4. All Parts: Duration of response (DoR)

    Measured: Up to approximately 5 years

  5. All Parts: Disease control rate (DCR)

    Measured: Up to approximately 5 years

  6. All Parts: Progression-free survival (PFS)

    Measured: Up to approximately 5 years

  7. All Parts: Overall survival (OS)

    Measured: Up to approximately 5 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted30 Oct 2026
  2. Study start31 Dec 2026 (estimated)
  3. Primary completion30 Mar 2032 (estimated)
  4. Study completion30 Mar 2032 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Sequential
Masking
None (open label)
Enrolment
540 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07905924
Sponsor's protocol ID
BP46586
Other IDs
2026-526415-11-00
Status last verified
Oct 2026
First submitted
23 Oct 2026
Last updated
30 Oct 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing RO7836748, Pembrolizumab and mFOLFIRINOX in people with Solid Tumors, run by Hoffmann-La Roche.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: opening soon, as of the sponsor's last update on 30 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Reference Study ID Number: BP46856 https://forpatients.roche.com/ No attachments to email below. (888-662-6728 (U.S. and Canada), global-roche-genentech-trials@gene.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Parts 1A and 1B: Incidence and Severity of Adverse Events (AEs) (time frame: From first dose up to approximately 5 years). The study lists 8 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07905924.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Oct 2026.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in