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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

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 1 year

Awards & highlights

Study 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.Check my eligibility

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.See study design

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.

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

maximum tolerated dose (MTD)

objective response rate (ORR) (Dose expansion)

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 / 4Eligibility criteria met

Find a Location

Who is running the clinical trial?

Curadev PharmaUNKNOWN

Memorial Sloan Kettering Cancer CenterLead Sponsor

1,936 Previous Clinical Trials

588,826 Total Patients Enrolled

70 Trials studying Sarcoma

13,695 Patients Enrolled for Sarcoma

Ciara Kelly, MBBCH BAOPrincipal InvestigatorMemorial Sloan Kettering Cancer Center

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What is the size of the sample population for this research endeavor?

"Affirmative. Clinicaltrials.gov contains evidence that this research endeavour, first posted on August 25th 2023, is accepting participants at the present time. 72 individuals will need to be recruited from 7 different medical centres for successful completion of the trial."

Answered by AI

Are they still seeking volunteers for this research project?

"Evidently, this medical trial is open to enrolling patients. Clinicaltrials.gov illustrates that the study was initially made available on August 25th 2023 and has been revised since then, with its latest update occurring on August 28th 2023."

Answered by AI

Has CRD3874-SI been certified for utilization by the Food and Drug Administration?

"Our evaluation at Power has determined that CRD3874-SI poses a low health risk, awarding it a score of 1. This is due to the restricted data available on its efficacy and safety as this drug is currently undergoing Phase 1 clinical trials."

Answered by AI

How many centers is this experiment being administered in?

"Seven medical centres are currently enrolling patients for this clinical trial. Memorial Sloan Kettering Monmouth (Limited Protocol Activities) in Middletown, Memorial Sloan Kettering Bergen (Limited Protocol Activities) in Montvale, and Memorial Sloan Kettering Suffolk - Commack (Limited Protocol Activities) in Commack are 3 of them, while other sites can be found across the country."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

A Study of CRD3874-SI in People With Sarcoma or Merkel Cell Cancer

2023. "A Study of CRD3874-SI in People With Sarcoma or Merkel Cell Cancer". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06021626.

All > Sarcoma > Merkel Cell Carcinoma