What side effects are associated with this type of intervention?

Common side effects of treatments for solid tumors, particularly those involving ATR inhibitors like camonsertib, PARP inhibitors, and chemotherapeutic agents such as gemcitabine, include fatigue, nausea, vomiting, diarrhea, and hematologic toxicities such as anemia, neutropenia, and thrombocytopenia. Patients may also experience increased susceptibility to infections, gastrointestinal disturbances, and, in some cases, more severe adverse events like major bleeding or hypertension. These side effects vary in severity and frequency depending on the specific treatment regimen and patient characteristics.

What prior FDA approvals exist?

The FDA has approved several treatments for solid tumors that involve mechanisms similar to those being studied in the RP-3500 (camonsertib) trial. PARP inhibitors such as olaparib, rucaparib, and niraparib have been approved for the treatment of various solid tumors, including ovarian, breast, and prostate cancers, particularly in patients with BRCA mutations or other homologous recombination repair deficiencies. Gemcitabine, a nucleoside analog used as chemotherapy, is also FDA-approved for treating several types of solid tumors, including pancreatic, lung, and bladder cancers. While specific ATR inhibitors may still be under investigation, these related treatments highlight the ongoing efforts to target DNA damage response pathways in cancer therapy.

What other types of research exist?

Promising novel alternatives to RP-3500 (camonsertib) for solid tumors include: 1) Entrectinib, which has shown efficacy in ROS1 fusion-positive non-small-cell lung cancer, 2) Lorlatinib, effective in advanced ROS1-positive non-small-cell lung cancer, and 3) Repotrectinib, which has demonstrated preliminary clinical activity in advanced ROS1 fusion-positive non-small cell lung cancer.

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Chemotherapy

RP-3500 for Solid Cancers

Phase 1 & 2

Recruiting

Led By Timothy A Yap, MBBS PhD FRCP

Research Sponsored by Repare Therapeutics

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Histologically confirmed solid tumors resistant or refractory to standard treatment and/or patients who are intolerant to standard therapy.

Existing biomarker profile (tumor tissue or plasma) reported from a local test obtained in a certified lab per institutional guidelines: Available tumor tissue.

Must not have

Patients with active, uncontrolled bacterial, fungal, or viral infection, including hepatitis B virus (HBV), hepatitis C virus (HCV), known human immunodeficiency virus (HIV) or acquired immunodeficiency syndrome (AIDS) related illness.

Prior therapy with an ATR or DNA-dependent protein kinase (DNA-PK) inhibitor.

Timeline

Screening 3 weeks

Treatment Varies

Follow Up about 1 year

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing a new oral drug, RP-3500, alone and with other drugs in patients with advanced cancers that have specific genetic mutations. The drug aims to stop cancer cells from fixing themselves, potentially shrinking or stopping the growth of the cancer.

Who is the study for?

Adults with advanced solid tumors and specific ATR inhibitor-sensitizing mutations can join this trial. They must have measurable disease, be in good physical condition (ECOG score of 0 or 1), and able to swallow pills. Participants need proper organ function, acceptable blood counts, and a negative pregnancy test if applicable. Contraception is required during the study and for six months after.

What is being tested?

The trial tests RP-3500 (camonsertib) alone or combined with talazoparib or gemcitabine to find the safest high dose for Phase 2 trials. It will assess safety, how the body processes these drugs, their effects on tumors, and overall anti-tumor activity.

What are the potential side effects?

Possible side effects include reactions related to drug tolerability such as fatigue, digestive issues like nausea or diarrhea, changes in blood counts leading to anemia or bleeding risks, potential liver dysfunction signs like jaundice or itchy skin.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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My cancer does not respond to standard treatments or I cannot tolerate them.

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My cancer's biomarker profile is available from a certified lab test.

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I can swallow and keep down pills.

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I am fully active or can carry out light work.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I do not have any active, uncontrolled infections including HBV, HCV, HIV, or AIDS.

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I have been treated with ATR or DNA-PK inhibitors before.

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My liver function is moderately or severely impaired.

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I have a history of irregular heartbeats or risk factors like heart disease.

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I haven't had cancer treatment in the last 14 days.

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I am allergic to ingredients in RP-3500 (camonsertib).

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I am taking medication that can affect my heart's rhythm.

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I have been diagnosed with MDS or AML.

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My high blood pressure is not under control.

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I do not have uncontrolled, symptomatic brain metastases.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ about 1 year

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~about 1 year

This trial's timeline: 3 weeks for screening, Varies for treatment, and about 1 year for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Safety and tolerability

Secondary study objectives

Assess CR+PR+SD (≥ 4 months) based on RECIST v1.1, confirmed CA-125 response by GCIG criteria, or PSA response based on PCWG3

Assess preliminary anti-tumor activity with Duration of Response (DOR) in patients with eligible advanced solid tumors by CT/MRI Response evaluation criteria in solid tumors (RECIST 1.1).

Assess preliminary anti-tumor activity with Overall Response Rate in patients with eligible advanced solid tumors by CT/MRI Response evaluation criteria in solid tumors (RECIST 1.1)

+5 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

3Treatment groups

Experimental Treatment

Group I: RP-3500 (camonsertib) with Talazoparib or GemcitabineExperimental Treatment3 Interventions

Phase 1: Multiple doses of RP-3500 (camonsertib) for oral administration in combination with talazoparib or gemcitabine

Group II: RP-3500 (camonsertib) aloneExperimental Treatment1 Intervention

Phase 1: Multiple doses of RP-3500 (camonsertib) for oral administration alone

Group III: Expansion cohorts with RP-3500 (camonsertib)Experimental Treatment1 Intervention

Phase 2: Expansion cohorts with RP-3500 (camonsertib)

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Talazoparib

2021

Completed Phase 2

~2810

Gemcitabine Injection

2014

Completed Phase 3

~100

0 / 14Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Common treatments for solid tumors often target specific molecular pathways to inhibit tumor growth and proliferation. ATR inhibitors like RP-3500 (camonsertib) work by targeting the ATR (ataxia telangiectasia and Rad3-related) protein, which is crucial for DNA damage response and repair. By inhibiting ATR, these treatments prevent cancer cells from repairing their DNA, leading to cell death, especially in tumors with existing DNA repair deficiencies. This is significant for solid tumor patients as it offers a targeted approach to kill cancer cells while potentially sparing normal cells, thereby reducing side effects and improving treatment efficacy.

Ra-223 Treatment for Bone Metastases in Castrate-Resistant Prostate Cancer: Practical Management Issues for Patient Selection.Novel molecular targets for the therapy of castration-resistant prostate cancer.