A Phase 1 interventional study of RO7836748 and Pembrolizumab in Solid Tumors, sponsored by Hoffmann-La Roche. Not yet recruiting. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-10-30.
Sponsored by Hoffmann-La Roche · Phase 1, Interventional, and Treatment
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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.
Hoffmann-La Roche is the lead sponsor of 2,101 studies on the registry; 88 are open to participants now.
Of its 330 completed or terminated interventional studies of FDA-regulated products, 248 (75%) have results posted.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The amount of disease can be tracked with a defined measurement, so the study can see whether it shrinks or grows. It might be a tumour measured on a scan or, in some blood cancers such as myeloma, a marker measured in blood or urine.
The criteria or the study team say which measurement counts — having no tumour visible on a scan does not by itself rule you out.
The standard rules for measuring tumours on CT or MRI scans, to tell whether a cancer is shrinking, stable or growing during treatment.
“Measurable disease per RECIST 1.1” usually means at least one tumour 10 mm or more at its longest on a CT scan, or a lymph node 15 mm or more across its short axis.
A scale of how much an illness limits everyday activity. For people being assessed to join a study, scores run from 0 (fully active) to 4; lower is more active.
Studies most often ask for 0–1 or 0–2. Your doctor gives the score; the WHO scale uses the same steps. The full scale also has 5, which records death.
The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.
A biopsy takes a small piece of tissue to examine. “Archival tissue” is a sample already taken, for example at diagnosis, and kept by the hospital.
Whether a stored sample will do depends on when it was taken, how much there is and what the study needs. Ask whether the study accepts your stored sample or needs a new biopsy.
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Relapsed: the illness came back after treatment had worked. Refractory: it did not respond to treatment, or stopped responding while still on it.
Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Cancer that has spread to the leptomeninges, the thin layers covering the brain and spinal cord, and the fluid between them. It is not the same as brain metastases.
Criteria often treat it separately, and many studies leave it out even where treated brain metastases are allowed.
Measurable disease
The amount of disease can be tracked with a defined measurement, so the study can see whether it shrinks or grows. It might be a tumour measured on a scan or, in some blood cancers such as myeloma, a marker measured in blood or urine.
The criteria or the study team say which measurement counts — having no tumour visible on a scan does not by itself rule you out.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
RECIST
The standard rules for measuring tumours on CT or MRI scans, to tell whether a cancer is shrinking, stable or growing during treatment.
“Measurable disease per RECIST 1.1” usually means at least one tumour 10 mm or more at its longest on a CT scan, or a lymph node 15 mm or more across its short axis.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ECOG performance status
A scale of how much an illness limits everyday activity. For people being assessed to join a study, scores run from 0 (fully active) to 4; lower is more active.
Studies most often ask for 0–1 or 0–2. Your doctor gives the score; the WHO scale uses the same steps. The full scale also has 5, which records death.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Life expectancy
The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Biopsy and archival tissue
A biopsy takes a small piece of tissue to examine. “Archival tissue” is a sample already taken, for example at diagnosis, and kept by the hospital.
Whether a stored sample will do depends on when it was taken, how much there is and what the study needs. Ask whether the study accepts your stored sample or needs a new biopsy.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hypersensitivity
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Relapsed and refractory
Relapsed: the illness came back after treatment had worked. Refractory: it did not respond to treatment, or stopped responding while still on it.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Metastases
Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Leptomeningeal disease
Cancer that has spread to the leptomeninges, the thin layers covering the brain and spinal cord, and the fluid between them. It is not the same as brain metastases.
Criteria often treat it separately, and many studies leave it out even where treated brain metastases are allowed.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Participants with advanced solid tumors (second line or higher \[2L+\]) with a RAS G12V mutation will receive increasing doses of RO7836748.
Drug: RO7836748
Participants 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.
Drug: RO7836748
Participants 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.
Drug: RO7836748
Participants 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.
Drug: RO7836748 · Drug: Pembrolizumab
Participants 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.
Drug: RO7836748 · Drug: mFOLFIRINOX
Participants 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.
Drug: RO7836748 · Drug: Cetuximab
Participants will receive RO7836748 as per the schedule described in the protocol.
Participants will receive pembrolizumab as per the schedule described in the protocol.
Participants will receive mFOLFIRINOX as per the schedule described in the protocol.
Participants will receive cetuximab as per the schedule described in the protocol.
Parts 1A and 1B: Incidence and Severity of Adverse Events (AEs)
Time frame: From first dose up to approximately 5 years
Part 2: Incidence and Severity of AEs
Time frame: From first dose up to approximately 5 years
Parts 3A, 3B and 3C: Incidence and Severity of AEs
Time frame: From first dose up to approximately 5 years
Parts 1A and 1B: Incidence of Dose-limiting Toxicities (DLTs)
Time frame: From Cycle 1 Day 1 (C1D1) until C1D21 (Cycle 1 = 21 days)
Part 3A: Incidence of DLTs
Time frame: From C1D1 until C1D21 (Cycle 1 = 21 days)
Parts 3B and 3C: Incidence of DLTs
Time frame: From C1D1 until C1D28 (Cycle 1 = 28 days)
Parts 1A and 1B: Recommended Dose for Expansion (RDE) of RO7836748 Monotherapy
Time frame: Up to approximately 5 years
Parts 3A, 3B, 3C: RDE of RO7836748 in Combination With Other Anti-Cancer Therapies
Time frame: Up to approximately 5 years
Parts 1A, 1B and 2: Plasma Concentrations of RO7836748 and its Metabolites as Monotherapy
Time frame: Up to approximately 5 years
Parts 3A, 3B and 3C: Plasma Concentrations of RO7836748 and its Metabolites in Combination With Other Anti-Cancer Therapies.
Time frame: Up to approximately 5 years
All Parts: Objective response rate (ORR)
Time frame: Up to approximately 5 years
All Parts: Duration of response (DoR)
Time frame: Up to approximately 5 years
All Parts: Disease control rate (DCR)
Time frame: Up to approximately 5 years
All Parts: Progression-free survival (PFS)
Time frame: Up to approximately 5 years
All Parts: Overall survival (OS)
Time frame: Up to approximately 5 years
No study locations are listed for this record.
Plan to share: No
Start is estimated for Dec 2026; primary completion for Mar 2032, 62 months later.
How these figures are worked out, and which studies are left out of them.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
This study is not yet recruiting, as verified in Oct 2026. You cannot join it, but the record below documents what was studied.
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