285 Participants Needed

RP-3500 for Solid Cancers

Recruiting at 12 trial locations
PM
MK
GG
Overseen ByGabriela Gomez, MD, MBA
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of this trial?

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.

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

The trial requires that you stop chemotherapy, small molecule anticancer, or biologic anticancer therapy at least 14 days before starting the study drug. If you are on medications that prolong the QT interval, you may also need to stop those. Other medications are not specifically mentioned, so consult with the trial team for guidance.

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

The trial requires that you stop chemotherapy, small molecule anticancer, or biologic anticancer therapy at least 14 days before starting the study drug. Other medications are not specifically mentioned, so it's best to discuss your current medications with the trial team.

What safety data is available for RP-3500 (camonsertib) and related treatments?

The research provided focuses on the safety and efficacy of Gemcitabine (Gemzar) in various cancer treatments. Gemcitabine has been studied in combination with other agents like interferon alpha, doxorubicin, and platinum compounds for different cancers, including renal cell carcinoma, breast cancer, and non-small-cell lung cancer. The studies report moderate toxicity levels, with common side effects including leukopenia, neutropenia, febrile neutropenia, anemia, mucositis, and diarrhea. However, there is no specific safety data for RP-3500 (camonsertib) or Talazoparib (Talzenna) in the provided research.12345

What safety data exists for RP-3500 (camonsertib) and related treatments like Gemcitabine (Gemzar) in humans?

Gemcitabine (Gemzar) has been studied in various cancers and generally shows moderate safety, with some patients experiencing blood-related side effects like low white blood cell counts and anemia, as well as mouth sores and diarrhea. These side effects are considered manageable, and the treatment is often combined with other drugs to improve effectiveness while monitoring for toxicity.12345

Is the drug combination of Gemcitabine, RP-3500, and Talazoparib promising for treating solid cancers?

Yes, the combination of Gemcitabine, RP-3500, and Talazoparib is promising for treating solid cancers. Gemcitabine has shown effectiveness in various cancers like breast, lung, and ovarian cancer, often improving survival and response rates when combined with other drugs. This suggests that combining it with RP-3500 and Talazoparib could enhance its effectiveness in treating solid cancers.12678

What makes the drug RP-3500 for solid cancers unique?

The drug RP-3500 (camonsertib) is unique because it combines gemcitabine, which has shown effectiveness in various cancers, with talazoparib, a PARP inhibitor that targets cancer cells with specific DNA repair weaknesses, potentially offering a novel mechanism of action and improved outcomes for solid cancers.12678

What data supports the idea that RP-3500 for Solid Cancers is an effective drug?

The available research shows that Gemcitabine (Gemzar), which is part of the RP-3500 treatment, has shown effectiveness in treating various solid cancers. For breast cancer, it has demonstrated better outcomes without severe side effects, especially when combined with other drugs, leading to longer survival and delayed disease progression. In non-small cell lung cancer (NSCLC), Gemcitabine combined with other drugs has shown increased effectiveness and fewer side effects compared to standard treatments. These findings suggest that RP-3500, which includes Gemcitabine, can be an effective option for treating solid cancers.12689

What data supports the effectiveness of the drug Gemcitabine (Gemzar) for solid cancers?

Gemcitabine (Gemzar) has shown effectiveness in treating various solid tumors, including breast cancer and non-small cell lung cancer, by improving outcomes like survival and time to disease progression when used alone or in combination with other drugs.12689

Who Is on the Research Team?

Timothy Yap | MD Anderson Cancer Center

Timothy Yap

Principal Investigator

M.D. Anderson Cancer Center

Are You a Good Fit for This Trial?

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.

Inclusion Criteria

I have recovered from all side effects of my previous cancer treatments or surgeries.
My cancer does not respond to standard treatments or I cannot tolerate them.
My cancer's biomarker profile is available from a certified lab test.
See 9 more

Exclusion Criteria

I do not have any active, uncontrolled infections including HBV, HCV, HIV, or AIDS.
I have been treated with ATR or DNA-PK inhibitors before.
My liver function is moderately or severely impaired.
See 10 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Dose Escalation

Evaluate the safety profile and MTD of RP-3500 (camonsertib) when administered orally, alone and in combination with talazoparib or gemcitabine

Up to 90 days

Expansion Cohorts

Expansion cohorts with RP-3500 (camonsertib) to study the anti-tumor effect and further examine the safety and PK at the RP2D

About 1 year

Follow-up

Participants are monitored for safety and effectiveness after treatment

Up to 90 days after last administration of study intervention

What Are the Treatments Tested in This Trial?

Interventions

  • Gemcitabine Injection [Gemzar]
  • RP-3500 (camonsertib)
  • Talazoparib
Trial Overview 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.
How Is the Trial Designed?
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)

Gemcitabine Injection [Gemzar] is already approved in European Union, United States, Canada, Japan for the following indications:

🇪🇺
Approved in European Union as Gemzar for:
  • Pancreatic cancer
  • Breast cancer
  • Non-small cell lung cancer
  • Ovarian cancer
🇺🇸
Approved in United States as Gemzar for:
  • Pancreatic cancer
  • Breast cancer
  • Non-small cell lung cancer
  • Ovarian cancer
🇨🇦
Approved in Canada as Gemzar for:
  • Pancreatic cancer
  • Breast cancer
  • Non-small cell lung cancer
  • Ovarian cancer
🇯🇵
Approved in Japan as Gemzar for:
  • Pancreatic cancer
  • Breast cancer
  • Non-small cell lung cancer
  • Ovarian cancer

Find a Clinic Near You

Who Is Running the Clinical Trial?

Repare Therapeutics

Lead Sponsor

Trials
10
Recruited
1,300+

Roche Pharma AG

Industry Sponsor

Trials
413
Recruited
430,000+
Dr. Thomas Schinecker profile image

Dr. Thomas Schinecker

Roche Pharma AG

Chief Executive Officer since 2023

PhD in Molecular Biology from New York University

Dr. Levi Garraway profile image

Dr. Levi Garraway

Roche Pharma AG

Chief Medical Officer since 2019

MD from University of California, San Francisco

Published Research Related to This Trial

In a phase I clinical trial involving 13 patients with metastatic renal cell carcinoma, the combination of gemcitabine and rHuIFN-alpha2b showed significant hematologic toxicity, particularly at higher doses, including severe anemia and neutropenia.
The study determined that the maximal tolerated dose was gemcitabine 600 mg/m2 weekly and rHuIFN-alpha2b 1.0 MU/m2 three times a week, leading to the conclusion that further investigation of this combination is not recommended due to the associated toxicities.
A phase I trial of weekly gemcitabine and subcutaneous interferon alpha in patients with refractory renal cell carcinoma.Perez-Zincer, F., Olencki, T., Budd, GT., et al.[2022]
Gemcitabine (Gemzar) has shown significant antitumor activity in breast cancer treatment, providing better outcomes without excessive toxicity, making it a promising option for patients.
In combination with paclitaxel, gemcitabine has established itself as a first-line treatment, improving response rates and survival, and is currently being investigated for its role in early-stage breast cancer as part of neoadjuvant therapy.
Integrating gemcitabine into breast cancer therapy.Yardley, DA.[2022]
Gemcitabine, a nucleoside analogue, shows promise in treating non-small cell lung cancer (NSCLC) and has been evaluated in economic studies across multiple countries, indicating it may be cost-effective compared to other treatments.
The economic evaluations suggest that gemcitabine can be administered safely in an outpatient setting with a lower side-effect profile, which contributes to its potential cost savings in NSCLC treatment.
Review of the pharmacoeconomic research on gemcitabine in the treatment of advanced non-small cell lung cancer.Minshall, ME., Liepa, AM.[2022]

Citations

A phase I trial of weekly gemcitabine and subcutaneous interferon alpha in patients with refractory renal cell carcinoma. [2022]
Integrating gemcitabine into breast cancer therapy. [2022]
Review of the pharmacoeconomic research on gemcitabine in the treatment of advanced non-small cell lung cancer. [2022]
Gemcitabine and UFT plus oral calcium folinate: phase I study. [2022]
Advances in treatment of inoperable NSCLC: gemcitabine doublets--a promising alternative. [2022]
A phase II study of neoadjuvant gemcitabine plus doxorubicin in stage IIIB breast cancer: a preliminary report. [2022]
Preclinical and clinical evaluation of four gemcitabine plus carboplatin schedules as front-line treatment for stage IV non-small-cell lung cancer. [2022]
Gemcitabine in combination with new platinum compounds: an update. [2022]
Gemcitabine in ovarian cancer. [2022]
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