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Monoclonal Antibodies

RGT-61159 for Cancer

Phase 1

Recruiting

Research Sponsored by Rgenta Therapeutics Inc

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Histologically confirmed ACC or CRC

Radiographically measurable disease as assessed per RECIST 1.1, with at least 1 site of disease that is measurable and that has not been previously irradiated; or, if the patient has had previous radiation to the target lesion(s), there must be evidence of progression since the radiation

Must not have

Chemotherapy within 14 days prior to Cycle 1 Day 1

Radiation therapy within 21 days prior to Cycle 1 Day 1

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 5 years

Awards & highlights

Summary

"This trial aims to test a new treatment called RGT-61159 in patients with ACC or CRCT to see if it is safe, well-tolerated, and effective against tumors."

Who is the study for?

Adults with Adenoid Cystic Carcinoma (ACC) or Colorectal Cancer (CRC) that has come back or hasn't responded to treatment can join this trial. Specific details about who can and cannot participate are not provided, but typically these would include health status and prior treatments.

What is being tested?

The study is testing RGT-61159's safety, how well it's tolerated by patients, and its effectiveness in fighting ACC or CRC tumors. This early-phase trial will help determine the appropriate dosage and gather preliminary data on its impact.

What are the potential side effects?

Specific side effects of RGT-61159 are not listed here, but common ones for cancer drugs may include nausea, fatigue, allergic reactions, blood count changes, and others depending on the drug's mechanism.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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My cancer is confirmed to be either adrenal cortical carcinoma or colorectal cancer.

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My cancer can be measured on scans and has grown after any previous radiation.

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My colorectal cancer cannot be removed by surgery or cured with radiation, and I've tried or can't have standard treatments.

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My blood, kidney, liver tests, and clotting times are within normal limits.

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My ACC has returned or worsened and can't be removed by surgery or treated with radiotherapy, and it has progressed in the last year.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I haven't had chemotherapy in the last 14 days.

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I have not had radiation therapy in the last 3 weeks.

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I have another active cancer besides the one being treated.

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I have had an organ transplant.

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I have been treated with a MYB inhibitor before.

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I have severe nausea, vomiting, or issues absorbing food.

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I have a serious heart condition.

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My diabetes is not well-managed.

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I do not have active liver disease or hepatitis A, B, or C.

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I have not had major surgery or a serious injury in the last 28 days.

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I am currently on treatment for a systemic infection.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 5 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 5 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 5 years for reporting.

Treatment Details

Trial Design

3Treatment groups

Experimental Treatment

Group I: Dose expansion Cohort BExperimental Treatment1 Intervention

Simon's 2 stage, RGT-61150 at optimized dose from Part A

Group II: Dose expansion Cohort AExperimental Treatment1 Intervention

Dose optimization; RGT-61159, 2 doses, randomized allocation

Group III: Dose escalationExperimental Treatment1 Intervention

RGT-61159 in escalating doses

0 / 16Eligibility criteria met

Find a Location

Who is running the clinical trial?

Rgenta Therapeutics IncLead Sponsor

~70 spots leftby Dec 2025

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