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Monoclonal Antibodies

CI-8993 for Solid Tumors

Phase 1

Waitlist Available

Research Sponsored by Curis, Inc.

Eligibility Criteria Checklist

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

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 2 years

Awards & highlights

Study Summary

This trial is testing a new drug, CI-8993, to see if it is safe and effective for patients with solid tumors that have not responded to other treatments.

Eligible Conditions

Solid Tumors

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 2 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~2 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and 2 years for reporting.

Treatment Details

Study Objectives

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

Primary outcome measures

Determine the Recommended Phase 2 dose (RP2D)

To determine the maximum tolerated dose of CI-8993

Secondary outcome measures

To assess anti-drug antibodies (ADA) of CI-8993

To assess duration of response (DOR)

To assess objective response rate (ORR)

+8 more

Trial Design

1Treatment groups

Experimental Treatment

Group I: CI-8993 dose escalationExperimental Treatment1 Intervention

Patients will be administered CI-8993 intravenously at a planned infusion rate over 2 hours at planned step-doses and subsequent full doses. The planned schedule of administration is every 2 weeks. The MTD of full doses of CI-8993 will be determined based on the occurrence of DLTs 28 days from the first full dose. Eligible patients may receive CI-8993 at the dose and schedule, according to their assigned cohorts, until disease progression or unacceptable toxicity.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

CI-8993

2020

Completed Phase 1

~30

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

Curis, Inc.Lead Sponsor

16 Previous Clinical Trials

1,088 Total Patients Enrolled

Frequently Asked Questions

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

How many participants are recruited to join this clinical trial?

"This medical trial requires 50 qualified subjects to enroll. Potential participants can attend from various sites, including the Roswell Park Cancer Institute in Buffalo, NY and Memorial Sloan Kettering Cancer Center in New york City."

Answered by AI

Has CI-8993 received permission from the FDA to be marketed?

"CI-8993's safety was evaluated as a 1, due to the early phase of this trial which only has limited evidence behind its efficacy and security."

Answered by AI

What are the envisioned outcomes of this investigation?

"As per the trial sponsor, Curis Inc., this study's primary objective is to determine the recommended phase 2 dose (RP2D). This outcome will be monitored for two years. Additionally, secondary outcomes include characterizing serum terminal elimination half-life (T 1/2), assessing response evaluation criteria in solid tumors version 1.1 (RECIST 1.1 ), and evaluating antibodies to CI-8993 in serum as a measure of anti-drug antibody production (ADA)."

Answered by AI

To what extent is this research study prevalent across different geographical sites?

"This study is being conducted in 5 different medical centres, including those located in Buffalo and Lebanon. To reduce any additional travel requirements associated with enrollment, it's wise to select the centre closest to you."

Answered by AI

Are recruitment efforts still active for this experiment?

"The clinicaltrials.gov page shows that this medical research is currently recruiting participants, with the original posting of September 22nd 2020 and an update on October 14th 2022."

Answered by AI

Recent research and studies

Modern PathologyJournal

Analysis of the Immune Checkpoint V-domain Ig-containing Suppressor of T-cell Activation (VISTA) in Endometrial Cancer

Zong, Liju, Shengwei Mo, Zezheng Sun, Zhaohui Lu, Shuangni Yu, Jie Chen, and Yang Xiang. 2021. “Analysis of the Immune Checkpoint V-domain Ig-containing Suppressor of T-cell Activation (VISTA) in Endometrial Cancer”. Modern Pathology. Springer Science and Business Media LLC. doi:10.1038/s41379-021-00901-y.

clinicaltrials.govStudy

Phase 1 Study of CI-8993 Anti-VISTA Antibody in Patients With Advanced Solid Tumor Malignancies

2020. "Phase 1 Study of CI-8993 Anti-VISTA Antibody in Patients With Advanced Solid Tumor Malignancies". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04475523.