Clinical trial · Interventional
Dose Escalation of RMC-5552 Monotherapy in Relapsed/Refractory Solid Tumors
A Phase 1/1b, Open-Label, Multicenter, Dose-Escalation Study of RMC 5552 Monotherapy in Adult Subjects With Relapsed/Refractory Solid Tumors
NCT04774952CI-TRIAL-00088565completedPhase 1ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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).
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Solid Tumors | Solid Neoplasm | CURATED_BROADER | 0.80 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| RMC-5552 | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- RMC-5552
- description
- RMC-5552 for IV administration
- interventionNames
- Drug: RMC-5552
Primary outcomes (2)
- measure
- Number of participants with adverse events (AEs)
- timeFrame
- up to 3 years
- description
- Incidence, nature, and severity of treatment-emergent AEs and serious AEs, including incidence and severity of findings in laboratory values or vital signs for RMC-5552 monotherapy
- measure
- Number of participants with dose limiting toxicities (DLTs)
- timeFrame
- 21 days
- description
- Incidence and nature of DLTs with RMC-5552 monotherapy
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Participants (male or female) ≥18 years of age * Participants who have advanced solid tumors that have failed, are intolerant to, or are considered ineligible for standard of care anticancer treatments including approved drugs for oncogenic drivers in their tumor type * Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1 * Participants in the Dose-Expansion Component must have molecular aberrations in the mTOR pathway * Adequate hematologic, hepatic and renal function Exclusion Criteria: * Known or suspected leptomeningeal or brain metastases or spinal cord compression * Primary central nervous system (CNS) tumors * Clinically significant cardiac disease * Active, clinically significant interstitial lung disease or pneumonitis * Subjects with abnormal fasting glucose, type 1 diabetes, or uncontrolled type 2 diabetes are excluded. * Subjects with stomatitis or mucositis of any grade
References
Publications (1)
- DERIVEDSchram AM, Naqash AR, Haura EB, Riess JW, Ulahannan SV, Ou SI, Munster PN, Cheng ML, Gustafson WC, Bitman B, Friedman R, Penn R, Kar S, Seshadri V, Wang Z, Tao L, Yang YC, Singh M, Burris HA, Meyerowitz JG. The Bi-steric, mTORC1-Selective Inhibitor, RMC-5552, in Advanced Solid Tumors: A Phase 1 Trial. Clin Cancer Res. 2025 Dec 1;31(23):4933-4943. doi: 10.1158/1078-0432.CCR-25-2112. PMID 41056387