Clinical Trials Logo

Clinical Trial Summary

The purpose of this study is to evaluate the safety, tolerability, pharmacokinetic (PK), and pharmacodynamic (PD) profiles of escalating doses of RMC-5552 monotherapy in adult participants with relapsed/refractory solid tumors and to identify the recommended Phase 2 dose (RP2D).


Clinical Trial Description

This is an open-label, multicenter, Phase 1/1b study of RMC-5552 monotherapy in participants with advanced relapsed or refractory solid tumors. The study will include 2 components: 1) a Dose-Escalation Component for participants with relapsed or refractory solid tumors and 2) a Dose-Expansion Component for participants with relapsed or refractory solid tumors harboring certain specific mutations/rearrangements that result in hyperactivation of the mTOR pathway. Participants will be treated until disease progression per RECIST v1.1, unacceptable toxicity, or other criteria for withdrawal are met, whichever occurs first. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT04774952
Study type Interventional
Source Revolution Medicines, Inc.
Contact
Status Active, not recruiting
Phase Phase 1
Start date April 7, 2021
Completion date March 31, 2024

See also
  Status Clinical Trial Phase
Active, not recruiting NCT00750841 - Study of the Effect of Rifampicin on the Pharmacokinetics (PK) of Multiple Doses of Cediranib in Patients With Solid Tumours Phase 1
Withdrawn NCT05419817 - Pembrolizumab With Sitravatinib in Recurrent Endometrial Cancer and Other Solid Tumors With Deficient Mismatch Repair System Phase 2
Completed NCT02828930 - A Study to Determine the Excretion Balance, Pharmacokinetics, Metabolism and Absolute Oral Bioavailability of a Single Oral Dose of [14C]-Labeled Idasanutlin and an Intravenous Tracer Dose of [13C]-Labeled Idasanutlin in a Single Cohort of Participants With Solid Tumors (Malignancies) Phase 1
Completed NCT01197170 - Hormone Receptor Positive Disease Across Solid Tumor Types: A Phase I Study of Single-Agent Hormone Blockade and Combination Approaches With Targeted Agents to Provide Synergy and Overcome Resistance Phase 1
Terminated NCT03225105 - M3541 in Combination With Radiotherapy in Solid Tumors Phase 1
Completed NCT03258515 - A Study to Investigate the Effect of Single Dose of AZD6094 (600 mg) on Cardiac Repolarization in Healthy Volunteers Phase 1
Completed NCT01497925 - Ph 1 Trial of ADI-PEG 20 Plus Docetaxel in Solid Tumors With Emphasis on Prostate Cancer and Non-Small Cell Lung Cancer Phase 1
Completed NCT01878890 - Phase I Dose Escalation Trial of Efavirenz in Solid Tumours or Non-Hodgkin Lymphoma in Therapeutic Failure. Phase 1
Active, not recruiting NCT05059522 - Continued Access Study for Participants Deriving Benefit in Pfizer-Sponsored Avelumab Parent Studies That Are Closing Phase 3
Active, not recruiting NCT03634982 - Dose Escalation of RMC-4630 Monotherapy in Relapsed/Refractory Solid Tumors Phase 1
Recruiting NCT04685226 - A Phase I/II Clinical Trial of ICP-723 in the Treatment of Advanced Solid Tumors Phase 1/Phase 2
Recruiting NCT03175224 - APL-101 Study of Subjects With NSCLC With c-Met EXON 14 Skip Mutations and c-Met Dysregulation Advanced Solid Tumors Phase 2
Recruiting NCT06036121 - A Study of ADRX-0706 in Select Advanced Solid Tumors Phase 1
Active, not recruiting NCT03258151 - Association of Genetic Polymorphisms With Docetaxel-based Chemotherapy Toxicities in Chinese Solid Tumor Patients
Completed NCT01528046 - Metformin in Children With Relapsed or Refractory Solid Tumors Phase 1
Recruiting NCT05325866 - A Study Evaluating Bemarituzumab in Solid Tumors With Fibroblast Growth Factor Receptor 2b (FGFR2b) Overexpression Phase 1/Phase 2
Recruiting NCT04557449 - Study to Test the Safety and Tolerability of PF-07220060 in Participants With Advance Solid Tumors Phase 1/Phase 2
Terminated NCT02890368 - Trial of Intratumoral Injections of TTI-621 in Subjects With Relapsed and Refractory Solid Tumors and Mycosis Fungoides Phase 1
Completed NCT02759640 - A Phase I Trial of HS-10241 in Solid Tumors Phase 1
Completed NCT02279433 - A First-in-human Study to Evaluate the Safety, Tolerability and Pharmacokinetics of DS-6051b Phase 1