Clinical trial · Interventional
A Trial of RSC-1255 for Treatment of Patients With Advanced Malignancies
A Phase Ia/Ib, Open Label, Multi-center, Non-randomized Dose Escalation and Dose Expansion Study of RSC-1255 Alone or in Combination With Hydroxychloroquine in Patients With Advanced Solid Tumor Malignancies
- 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)
RSC-101 is a Phase 1a/1b clinical trial of RSC-1255 in adult study participants with advanced solid tumor malignancies who are intolerant of existing therapies known to provide clinical benefit, have disease that has progressed after standard therapy, or have previously failed other therapies. The study has two phases. The purpose of Phase 1a (Dose Escalation) is to confirm the appropriate treatment dose and Phase 1b (Dose Expansion) is to characterize the safety and efficacy of RSC-1255.
Conditions
Conditions (6)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Advanced Malignant Solid Neoplasm | Malignant Solid Neoplasm | CURATED_BROADER | 0.78 |
| Colon Cancer | Malignant Colon Neoplasm | CURATED_EXACT | 0.92 |
| Glioblastoma | Glioblastoma | CURATED_BROADER | 0.80 |
| Lung Cancer | Malignant Lung Neoplasm | CURATED_EXACT | 0.92 |
| Pancreatic Cancer | Malignant Pancreatic Neoplasm | CURATED_EXACT | 0.92 |
| RAS Mutation | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| RSC-1255 Dose Escalation | Drug | — | UNRESOLVED |
| RSC-1255 Dose Expansion | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- RSC-1255 Treatment
- description
- Single Arm Study. All study participants receive RSC-1255.
- interventionNames
- Drug: RSC-1255 Dose Escalation
- Drug: RSC-1255 Dose Expansion
Primary outcomes (2)
- measure
- Maximum Tolerated Dose (MTD) for RSC-1255 as monotherapy
- timeFrame
- Approximately 30 months
- description
- The number and type of dose-limiting toxicities (DLTs) as defined in the protocol that occur during the first 21 days of treatment and maximum grade of all treatment-related events using CTCAE V5.0 will be used to identify a safe and tolerable dose.
- measure
- Recommended Phase 2 Dose (RP2D) for RSC-1255 as monotherapy
- timeFrame
- Approximately 12 months
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria (Key Factors): 1. Has pathologically confirmed advanced or metastatic malignancy characterized by one or more of the following: * Participant is intolerant of existing therapy(ies) known to provide clinical benefit for their condition * Malignancy is refractory to existing therapy(ies) known to potentially provide clinical benefit * Malignancy has progressed on standard therapy 2. Has evaluable or measurable tumor(s) in dose-escalation by standard radiological and/or laboratory assessments as applicable to their malignancy. 3. Has adequate performance status (PS): Eastern Co-operative Oncology Group (ECOG). 4. Is age ≥ 18 years. 5. Has either tissue agnostic tumors and documented RAS mutations or with glioblastoma with or without mutation in RAS Exclusion Criteria (Key Factors): 1. Participants receiving cancer therapy at the time of enrollment. 2. Any clinically significant disease or condition affecting a major organ system. 3. Significant cardiovascular disease or electrocardiogram (ECG) abnormalities. 4. Known Gilbert's disease. 5. Has had a previous (within 2 years) or has a current malignancy other than the target cancer. 6. Intermittent hypokalemia 7. Grade 1 or higher nausea, vomiting, diarrhea at baseline due to underlying disease
References
Publications (0)
Data not yet available