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Monoclonal Antibodies
CLN-418 for Solid Tumors
Phase 1
Recruiting
Research Sponsored by Cullinan Oncology Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Male or female subject aged ≥18 years old at the time of screening
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up from time of consent until the first documented disease progression, unacceptable toxicity, withdrawal of consent, lack of treatment benefits, death or study termination whichever comes first, assessed up to 12 months
Awards & highlights
Study Summary
This trial is to see if a new drug is safe and how well it works.
Who is the study for?
Adults aged 18+ with advanced solid tumors like breast, ovarian, or lung cancer, who need new treatment options and have good organ function. Not for those with autoimmune diseases, heart issues, recent other cancer treatments, unresolved surgery effects or certain infections.Check my eligibility
What is being tested?
The trial is testing CLN-418 to find the highest dose patients can take without serious side effects and to decide on a recommended dose for future studies. It's in two parts: first finding the safe dose level then using it in specific cancers.See study design
What are the potential side effects?
While not specified here, similar trials may include side effects such as fatigue, nausea, skin reactions at injection sites and potential immune system-related conditions due to the investigational nature of CLN-418.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am 18 years old or older.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ from time of consent until the first documented disease progression, unacceptable toxicity, withdrawal of consent, lack of treatment benefits, death or study termination whichever comes first, assessed up to 12 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~from time of consent until the first documented disease progression, unacceptable toxicity, withdrawal of consent, lack of treatment benefits, death or study termination whichever comes first, assessed up to 12 months
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Proportion of subjects with dose-limiting toxicity (DLT)
Secondary outcome measures
Adverse events (AEs) according to Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0
Anti-drug antibodies
Disease control rate
+6 moreTrial Design
2Treatment groups
Experimental Treatment
Group I: CLN-418: Part 2Experimental Treatment1 Intervention
Experimental Part 2: Dose Expansion
Treatment administered at Maximum Tolerated Dose (MTD) and / or Recommended Phase 2 Dose (RP2D) established in Part 1
Group II: CLN-418: Part 1Experimental Treatment1 Intervention
Experimental Part 1: Dose escalation
Intravenous IV administrations of CLN-418 on Day 1 of each 21 day treatment cycle
Dose for cohorts to be confirmed following consultation and approval by Safety Review Committee
Find a Location
Who is running the clinical trial?
Cullinan Oncology Inc.Lead Sponsor
5 Previous Clinical Trials
660 Total Patients Enrolled
Cullinan Therapeutics Inc.Lead Sponsor
6 Previous Clinical Trials
690 Total Patients Enrolled
Cullinan Oncology, LLCLead Sponsor
6 Previous Clinical Trials
944 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have an advanced solid tumor or specific cancer with no curative treatment options.I haven't had cancer treatments like immunotherapy or targeted therapy in the last 4 weeks.I am still recovering from surgery or side effects from previous cancer treatment.I have previously received anti-B7H4 or anti-4-1BB antibody treatment.I have not needed antibiotics or antivirals for an infection in the last 3 weeks.I have brain or CNS metastases that are symptomatic or untreated.I am 18 years old or older.I have or had hepatitis B or C.I have HIV/AIDS.I have a serious heart condition.My organs and bone marrow are working well.I have a history of liver disease, including cirrhosis or fatty liver disease not caused by alcohol.
Research Study Groups:
This trial has the following groups:- Group 1: CLN-418: Part 1
- Group 2: CLN-418: Part 2
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
What potential adverse effects might patients experience from taking HBM 7008?
"Due to the limited available data regarding HBM 7008's efficacy and safety, we at Power rate this drug as a 1 on our scale."
Answered by AI
Is there an ongoing recruitment process for this experiment?
"As displayed on clinicaltrials.gov, this medical trial is presently accepting patient applications. It was originally posted on May 12th 2022 and has had its details revised as recently as September 1st 2022."
Answered by AI
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