RO7673396 for Cancer

Recruiting at 18 trial locations

Overseen By Reference Study ID Number: YO45758 https://forpatients.roche.com/

Age: 18+

Sex: Any

Trial Phase: Phase 1

Sponsor: Hoffmann-La Roche

Must not be taking: Chemotherapy, Immunotherapy

Disqualifiers: CNS metastases, Liver disease, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

345 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new treatment called RO7673396, an experimental therapy, to determine its safety for individuals with advanced solid tumors that have a RAS mutation, a type of genetic change. The trial consists of two stages: the first identifies the optimal dose, and the second evaluates the treatment's effectiveness against the tumors. Suitable participants have incurable solid tumors with this specific RAS mutation. As a Phase 1 trial, the research focuses on understanding how the treatment works in people, offering participants the opportunity to be among the first to receive this new therapy.

Do I need to stop my current medications to join the trial?

The trial requires that you have not received chemotherapy, immunotherapy, biologic therapy, or an investigational agent as anti-cancer therapy within 4 weeks or five half-lives before starting the study treatment. Other medications are not specifically mentioned, so it's best to discuss your current medications with the trial team.

Is there any evidence suggesting that RO7673396 is likely to be safe for humans?

Research has shown that RO7673396 is being tested for safety and tolerability in individuals with advanced solid tumors that have RAS mutations. This Phase 1 trial marks the initial stage of testing this treatment in humans. The primary goal is to determine a safe dose and assess how well participants tolerate the drug.

Detailed information about side effects or tolerability is not yet available. This phase focuses on identifying potential risks and side effects. As the trial is in its early stages, some side effects are expected as researchers work to establish the optimal dose to minimize them.

In summary, while specific safety data on RO7673396 is not yet available, this trial aims to gather information on its safety in humans and participant tolerability. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising?

Unlike the standard treatments for cancers with RAS mutations, which often include chemotherapy and targeted therapies, RO7673396 offers a novel approach. This treatment specifically targets RAS mutations, which are notoriously difficult to treat, using an innovative mechanism of action. Researchers are excited because RO7673396 could potentially provide a more precise and effective option, reducing the reliance on broader, less targeted therapies. This specificity might lead to better outcomes and fewer side effects for patients.

What evidence suggests that RO7673396 might be an effective treatment for cancer?

Research shows that RO7673396 targets tumors with specific RAS mutations. These mutations often cause cancer to grow, so blocking them can slow or stop tumor growth. Early studies suggest promise, as lab tests have shown it can halt cancer cell growth. Although human studies provide limited information, the mechanism of RO7673396 suggests it could effectively slow advanced solid tumors with these mutations. Participants in this trial will receive RO7673396 in two stages: Stage I involves multiple ascending doses, and Stage II uses the dose determined in Stage I. Early results from ongoing trials are needed to confirm these effects in people. ^{1 2 4 6 7}

Who Is on the Research Team?

Clinical Trials

Principal Investigator

Hoffmann-La Roche

Are You a Good Fit for This Trial?

This trial is for adults with advanced solid tumors that have a specific RAS mutation. They should be in relatively good physical condition (ECOG status of 0 or 1), expected to live at least 12 weeks, and have measurable disease according to certain medical criteria. Their blood counts and organ functions must also meet the study's requirements.

Inclusion Criteria

My cancer can be measured for changes and I am fully active or restricted in physically strenuous activity only.

My doctor expects me to live for at least 12 more weeks.

My cancer has a confirmed RAS mutation.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Dose Escalation

Participants receive multiple ascending doses of RO7673396 to determine the recommended dose for expansion

Until unacceptable toxicity or disease progression

Dose Expansion

Participants receive RO7673396 at the recommended dose to evaluate preliminary anti-tumor activity

Until unacceptable toxicity or disease progression

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• RO7673396

Trial Overview The trial is testing RO7673396, a new potential treatment for cancer. It has two parts: first, finding the best dose (Dose Escalation), then seeing how well it works at that dose on different types of tumors (Dose Expansion).

How Is the Trial Designed?

Group I: Stage II Experimental Treatment 1 Intervention

Participants with advanced solid tumors harboring RAS mutations will receive RO7673396 at the dose determined in Stage 1, until unacceptable toxicity or disease progression and/or loss of clinical benefit as determined by the investigator.

Group II: Stage I Experimental Treatment 1 Intervention

Participants with advanced solid tumors harboring RAS mutations will receive multiple ascending doses of RO7673396, as per a pre-defined dosing regimen until unacceptable toxicity or disease progression and/or loss of clinical benefit as determined by the investigator.

Who Is Running the Clinical Trial?

Hoffmann-La Roche

Lead Sponsor

Trials

2,482

Recruited

1,107,000+

Headquarters

Basel, Switzerland

Known For

Precision medicine

Top Products

Avastin, Herceptin, Rituxan, Accu-Chek

Dr. Levi Garraway

Hoffmann-La Roche

Chief Medical Officer since 2019

MD from the University of Basel

Dr. Thomas Schinecker

Hoffmann-La Roche

Chief Executive Officer since 2023

PhD in Molecular Biology from New York University

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT06884618

NCT06884618 | A Study to Evaluate the Safety, Tolerability ... This study aims to evaluate the safety and tolerability of RO7673396 in participants with advanced solid tumors harboring RAS mutation(s).

2. medicine.yale.edu medicine.yale.edu/ycci/clinicaltrials/trial/a-phase-i-study-of-ro7673396-in-patients-with-advanced-solid-tumors/

A Phase I Dose Escalation and Expansion Study to Evaluate ... This study aims to evaluate the safety and tolerability of RO7673396 in participants with advanced solid tumors harboring RAS mutation(s).

3. withpower.com withpower.com/trial/phase-1-neoplasms-3-2025-43cbe

RO7673396 for Cancer · Recruiting Participants for Phase ... This study aims to evaluate the safety and tolerability of RO7673396 in participants with advanced solid tumors harboring RAS mutation(s).

4. hkexnews.hk hkexnews.hk/listedco/listconews/sehk/2025/0911/11837299/2025091100061_c.pdf

China Anti-tumor and Autoimmune Disease Efficacy &. Safety. Country. /region. First posted date. PF-07985045 advanced solid tumors,. NSCLC, CRC, PDAC. Phase 1. Pfizer mono or combo ...

5. australianclinicaltrials.gov.au australianclinicaltrials.gov.au/anzctr-search-results?condition_category=all&condition_code=all&ethics_approval=all&gender=all&healthy_volunteers=all&phase=all&purpose_of_study=all&recruitment_sites=VIC&recruitment_status=all&search_text=&page=704

ANZCTR search results | Australian Clinical ... This study aims to evaluate the safety and tolerability of RO7673396 in participants with advanced solid tumors harboring RAS mutation(s). This study ...

6. clin.larvol.com clin.larvol.com/trial-detail/NCT06884618

NCT06884618 Impact Score 2A Study to Evaluate the Safety, Tolerability, Pharmacokinetics (PK) and Preliminary Clinical Activity of RO7673396 in Participants With ...

7. synapse.patsnap.com synapse.patsnap.com/drug/a14253f2af2d4d2d90b5866838d4c2f2

RO-7673396 - Drug Targets, Indications, Patents A Phase I Dose Escalation and Expansion Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Preliminary Clinical Activity of RO7673396 as a ...