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CRD3874-SI for Sarcoma

Phase 1

Recruiting

Led By Ciara Kelly, MBBCH BAO

Research Sponsored by Memorial Sloan Kettering Cancer Center

Eligibility Criteria Checklist

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

Must have

In the dose escalation phase an upper bound weight limit restriction will be used for dose levels 5 and 6. Hence, patients must weight ≤90kg and ≤70kg in order to be eligible to enroll in dose level 5 and 6 of the dose escalation phase, respectively

Patients must have a locally advanced or metastatic cancer that has progressed on at least one line of systemic therapy or for which no standard treatment is available, or the participant is intolerant to available treatment

Must not have

History or evidence of symptomatic autoimmune disease, or history of active autoimmune disease that has required systemic treatment in past 2 years prior to enrollment

Has known active central nervous system (CNS) metastases and/or carcinomatous meningitis

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 1 year

Awards & highlights

No Placebo-Only Group

Summary

This trial will test the safety of a drug called CRD3874-SI, looking for the highest dose with few or mild side effects. Then it will be tested to see if it is an effective treatment for Sarcoma & Merkel Cell Cancer.

Who is the study for?

This trial is for adults with advanced or metastatic sarcoma, Merkel cell carcinoma, or neuroendocrine carcinoma that's worsened after treatment. They must be in good health otherwise, have a life expectancy of at least three months, and not be pregnant. Participants need to agree to biopsies and have measurable disease. Those with certain heart conditions, active infections, other cancers, severe allergies to study drug components or recent treatments are excluded.

What is being tested?

CRD3874-SI is being tested in this study. Researchers will first find the highest dose with acceptable side effects before testing its effectiveness against specific cancers like Sarcoma and Merkel Cell Cancer. The trial involves gradually increasing doses for early participants then using the safest high dose on later groups.

What are the potential side effects?

While detailed side effects aren't listed here, CRD3874-SI may cause mild to moderate reactions depending on the dosage level reached during trials. Side effects typically relate to how well the body tolerates new drugs and can range from minor issues like headaches or nausea to more serious complications.

Eligibility Criteria

Inclusion Criteria

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

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I weigh ≤90kg for dose level 5 or ≤70kg for dose level 6.

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My cancer is advanced or has spread, and it got worse after treatment or I can't tolerate the treatment.

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My sarcoma or Merkel cell carcinoma has worsened despite anti-PD-1/PD-L1 treatment.

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I am fully active or able to carry out light work.

Exclusion Criteria

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

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I have an autoimmune disease that required treatment in the last 2 years.

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I have cancer that has spread to my brain or spinal cord.

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I have not received a live vaccine in the last 30 days.

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I have an active tuberculosis infection.

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I am not pregnant or breastfeeding.

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I haven't had recent cancer treatments or still recovering from their side effects.

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I have a history of lung disease not caused by an infection.

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I have HIV that is not well-controlled.

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I have had an organ or stem-cell transplant.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 1 year

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~1 year

This trial's timeline: 3 weeks for screening, Varies for treatment, and 1 year for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

maximum tolerated dose (MTD)

objective response rate (ORR) (Dose expansion)

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups

Experimental Treatment

Group I: CRD3874-SIExperimental Treatment1 Intervention

Phase 1a: starting dose of 0.1 mg/kg, Phase 1b: RP2D determined during Phase 1a. Cycle 1 \& 2: once weekly infusion x 4 (Days 1, 8, 15, 22) over 28-day cycle. Cycle 3 onwards: weekly infusion x 3 (Days 1, 8, 15) over 28-day cycle

0 / 13Eligibility criteria met