Advanced Malignant Solid NeoplasmPhase 1NCT04678648
A Trial of RSC-1255 for Treatment of Patients With Advanced Malignancies
A Phase 1 study testing RSC-1255 Dose Escalation and RSC-1255 Dose Expansion in people with Advanced Malignant Solid Neoplasm and RAS Mutation, run by RasCal Therapeutics, Inc. at 3 sites in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Advanced Malignant Solid Neoplasm, RAS Mutation, Lung Cancer
- What is being tested?
- RSC-1255 Dose Escalation and RSC-1255 Dose Expansion
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 134 participants
- Where
- 3 sitesUnited States
- Study dates
- 3 Mar 2021to 30 Jan 2027
- Phase
- Phase 1
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
- Has evaluable or measurable tumor(s) in dose-escalation by standard radiological and/or laboratory assessments as applicable to their malignancy.
- Has adequate performance status (PS): Eastern Co-operative Oncology Group (ECOG).
- Is age ≥ 18 years.
- Has either tissue agnostic tumors and documented RAS mutations or with glioblastoma with or without mutation in RAS
Who cannot join
- Participants receiving cancer therapy at the time of enrollment.
- Any clinically significant disease or condition affecting a major organ system.
- Significant cardiovascular disease or electrocardiogram (ECG) abnormalities.
- Known Gilbert's disease.
- Has had a previous (within 2 years) or has a current malignancy other than the target cancer.
- Intermittent hypokalemia
- Grade 1 or higher nausea, vomiting, diarrhea at baseline due to underlying disease
Trial locations and contacts
3 sites in 1 country. Contact the study team or a site near you to ask about taking part.
United States3 sites, 3 recruiting
- Recruiting
Sarah Cannon, SCRI Oncology Partners - Health One
Denver, Colorado, 80218
- Recruiting
University of California, Los Angeles (UCLA) Department of Medicine - Hematology/Oncology
Los Angeles, California, 90404
- Recruiting
Sarah Cannon, SCRI Oncology Partners
Nashville, Tennessee, 37203
About this study
Official title: 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
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.
Read the detailed description
RSC-1255 is an orally bioavailable, small-molecule direct pan-mutant and wild-type RAS inhibitor. RSC-101 is a Phase 1a/1b, open-label, multi-center, non-randomized, Dose Escalation and Dose Expansion study in participants with advanced solid tumor malignancies. Study enrollment is approximately 134 participants. All participants receive oral RSC-1255, twice daily as monotherapy. Following Phase 1a (Dose Escalation) to identify the Maximum Tolerated Dose and Recommended Dose for use in Phase 1b, additional participants are enrolled in the Phase 1b (Dose Expansion) to further characterize the safety, pharmacology, and the clinical efficacy of RSC-1255 as monotherapy and in combination with the autophagy inhibitor hydroxychloroquine (HCQ).
- Conditions
- Advanced Malignant Solid Neoplasm, RAS Mutation, Lung Cancer, Colon Cancer, Glioblastoma, Pancreatic Cancer
- Being tested
- RSC-1255 Dose Escalation, RSC-1255 Dose Expansion
- Keywords
- Malignancy, Cancer, Refractory, RAS mutation, Lung, Colon, Glioblastoma, RSC-1255, Progression, Pancreatic
- Medical subject headings
- Lung Neoplasms, Colonic Neoplasms, Glioblastoma, Pancreatic Neoplasms, Neoplasms, Disease Progression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RSC-1255 Dose EscalationDrug
Also called Phase 1a, Dose Escalation
Phase 1a will enroll 40-80 participants to identify the dose limiting toxicity (DLT), recommended Phase 1b dose, and the safety and tolerability of RSC-1255. RSC-1255 is administered orally twice daily, with and without food. Each cycle is 21 days.
RSC-1255 Dose ExpansionDrug
Also called Phase 1b, Dose Expansion
Phase 1b will enroll 48-94 participants to further characterize the safety, pharmacology, and clinical efficacy of RSC-1255. RSC-1255 is administered orally twice daily alone or in combination with continuous hydroxychloroquine, with food. Each cycle is 21 days.
| Study group | Role | What they receive |
|---|---|---|
| RSC-1255 Treatment | Experimental | Single Arm Study. All study participants receive RSC-1255. Receives: Drug: RSC-1255 Dose Escalation; Drug: RSC-1255 Dose Expansion |
What is being measured
The primary outcome is the main question the study is designed to answer.
Maximum Tolerated Dose (MTD) for RSC-1255 as monotherapy
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.
Measured: Approximately 30 months
Recommended Phase 2 Dose (RP2D) for RSC-1255 as monotherapy
The number and type of DLTs as defined in the protocol that occur during the first 21 days of treatment and maximum grade of all treatment-related adverse events using CTCAE 5.0 will be used to identify a safe and tolerable dose.
Measured: Approximately 12 months
Secondary outcomes (3)
Adverse event profile of RSC-1255
Toxicities will be graded according to CTCAE V5.0.
Measured: Approximately 24 months
Overall Survival (OS)
Overall Survival
Measured: Approximately 24 months
Disease Progression
Disease Progression will be assessed using RECIST V1.1
Measured: Approximately 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Dec 2020
- Study start3 Mar 2021
- Primary completion15 Dec 2026 (estimated)
- Study completion30 Jan 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Advanced Malignant Solid NeoplasmStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 134 participants (estimated)
Sponsor and investigators
- Lead sponsor
- RasCal Therapeutics, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Michael Mann, MD, Study director, RasCal Therapeutics, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04678648
- Sponsor's protocol ID
- RSC-101
- Status last verified
- Jun 2026
- First submitted
- 8 Dec 2020
- Last updated
- 23 Jun 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT04678648
- Acronym / sponsor ID
- RSC-101
- Conditions
- Advanced Malignant Solid Neoplasm, RAS Mutation, Lung Cancer, Colon Cancer, Glioblastoma, Pancreatic Cancer
- Keywords
- Malignancy, Cancer, Refractory, RAS mutation, Lung, Colon, Glioblastoma, RSC-1255
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 134 participants (estimated)
- Lead sponsor
- RasCal Therapeutics, Inc.Industry (pharma, biotech, devices)
- Study start
- 3 Mar 2021 (actual)
- Primary completion
- 15 Dec 2026 (estimated)
- Study completion
- 30 Jan 2027 (estimated)
- First posted
- 22 Dec 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
RSC-1255 is an orally bioavailable, small-molecule direct pan-mutant and wild-type RAS inhibitor. RSC-101 is a Phase 1a/1b, open-label, multi-center, non-randomized, Dose Escalation and Dose Expansion study in participants with advanced solid tumor malignancies. Study enrollment is approximately 134 participants. All participants receive oral RSC-1255, twice daily as monotherapy. Following Phase 1a (Dose Escalation) to identify the Maximum Tolerated Dose and Recommended Dose for use in Phase 1b, additional participants are enrolled in the Phase 1b (Dose Expansion) to further characterize the safety, pharmacology, and the clinical efficacy of RSC-1255 as monotherapy and in combination with the autophagy inhibitor hydroxychloroquine (HCQ).
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| RSC-1255 Treatment | Experimental | Drug: RSC-1255 Dose Escalation, Drug: RSC-1255 Dose ExpansionSingle Arm Study. All study participants receive RSC-1255. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Has pathologically confirmed advanced or metastatic malignancy characterized by one or more of the following:
- Has evaluable or measurable tumor(s) in dose-escalation by standard radiological and/or laboratory assessments as applicable to their malignancy.
- Has adequate performance status (PS): Eastern Co-operative Oncology Group (ECOG).
- Is age ≥ 18 years.
- Has either tissue agnostic tumors and documented RAS mutations or with glioblastoma with or without mutation in RAS
Key exclusion criteria (7 listed)
- Participants receiving cancer therapy at the time of enrollment.
- Any clinically significant disease or condition affecting a major organ system.
- Significant cardiovascular disease or electrocardiogram (ECG) abnormalities.
- Known Gilbert's disease.
- Has had a previous (within 2 years) or has a current malignancy other than the target cancer.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| RSC-1255 Dose EscalationAlso: Phase 1a, Dose EscalationPhase 1a will enroll 40-80 participants to identify the dose limiting toxicity (DLT), recommended Phase 1b dose, and the safety and tolerability of RSC-1255. RSC-1255 is administered orally twice daily, with and without food. Each cycle is 21 days. | Drug | RSC-1255 Treatment |
| RSC-1255 Dose ExpansionAlso: Phase 1b, Dose ExpansionPhase 1b will enroll 48-94 participants to further characterize the safety, pharmacology, and clinical efficacy of RSC-1255. RSC-1255 is administered orally twice daily alone or in combination with continuous hydroxychloroquine, with food. Each cycle is 21 days. | Drug | RSC-1255 Treatment |
Primary outcome
Maximum Tolerated Dose (MTD) for RSC-1255 as monotherapy
Time frame: Approximately 30 months
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.
Recommended Phase 2 Dose (RP2D) for RSC-1255 as monotherapy
Time frame: Approximately 12 months
The number and type of DLTs as defined in the protocol that occur during the first 21 days of treatment and maximum grade of all treatment-related adverse events using CTCAE 5.0 will be used to identify a safe and tolerable dose.
3 secondary outcomes
Adverse event profile of RSC-1255
Time frame: Approximately 24 months
Overall Survival (OS)
Time frame: Approximately 24 months
Disease Progression
Time frame: Approximately 24 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jun 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Michael Mann, MD study director
RasCal Therapeutics, Inc.
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing RSC-1255 Dose Escalation and RSC-1255 Dose Expansion in people with Advanced Malignant Solid Neoplasm and RAS Mutation, run by RasCal Therapeutics, Inc. at 3 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 23 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Michael Mann, MD (310-498-7171, clinicaltrials@rascaltherapeutics.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Maximum Tolerated Dose (MTD) for RSC-1255 as monotherapy (time frame: Approximately 30 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Jun 2026.