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Monoclonal Antibodies
ADA-011 + PD(L)-1 Inhibitor for Solid Tumors
Phase 1
Recruiting
Research Sponsored by Adanate, 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 36 months
Awards & highlights
Study Summary
This trial evaluates the safety and effectiveness of a new drug, ADA-011, alone and with another drug, to treat certain illnesses. Dose levels are increased to find the best dose.
Who is the study for?
This trial is for adults with advanced solid tumors that can't be removed or have come back after treatment, and there's no standard therapy left to try. They should be fairly active (ECOG ≤2), have measurable tumor growth, and their organs must work well. People with severe autoimmune diseases, unresolved side effects from past cancer treatments (except hair loss), infections including COVID-19, recent antineoplastic therapies or surgeries, high-dose steroid use, organ transplants, brain disease involvement or serious drug-related brain toxicity are excluded.Check my eligibility
What is being tested?
The study tests ADA-011 alone and combined with a checkpoint inhibitor in people with advanced solid tumors. It starts by finding the safest dose of ADA-011 (dose escalation) and then checks its safety and early results on tumor control at this dose in more patients (dose expansion).See study design
What are the potential side effects?
Potential side effects include typical reactions to immune therapies like inflammation in various organs which might cause symptoms depending on the area affected (e.g., lung inflammation causing breathlessness), fatigue, possible infusion-related reactions such as fever or chills during administration of the drug(s), as well as risks associated with PD(L)-1 inhibitors.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 36 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~36 months
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Number of Dose-Limiting Toxicities (DLTs)
Number of Participants Who Experienced an Adverse Event (AE)
Secondary outcome measures
Pharmacokinetic (PK) Profile of Participants Treated with ADA-011 (AUC)
Pharmacokinetic (PK) Profile of Participants Treated with ADA-011 (Cmax)
Other outcome measures
Number of Participants Positive for Anti-Drug Antibodies (ADA) After Treatment with ADA-011
Objective Response Rate (ORR) per Response Evaluation Criteria in Solid Tumors (RECIST) 1.1
Trial Design
3Treatment groups
Experimental Treatment
Group I: Combination Therapy Dose EscalationExperimental Treatment2 Interventions
Combination therapy with ADA-011 and PD(L)-1 inhibitor (at escalating ADA-011 doses) will be administered IV Q3W, starting with Cycle 1, Day 1 in participants with histologically or cytologically confirmed solid tumors.
Group II: ADA-011 Monotherapy Dose ExpansionExperimental Treatment1 Intervention
ADA-011 monotherapy with the preliminary recommended phase 2 dose (RP2D) of ADA-011, in participants with histologically or cytologically confirmed solid tumors.
Group III: ADA-011 Monotherapy Dose EscalationExperimental Treatment1 Intervention
ADA-011 monotherapy will be administered intravenously (IV), every 3 weeks (Q3W) at escalating doses starting with Cycle 1, Day 1, until participant withdrawal. Participants enroll with histologically or cytologically confirmed solid tumors.
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Who is running the clinical trial?
Adanate, IncLead Sponsor
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- My cancer is advanced, cannot be surgically removed, and is getting worse despite treatment.I do not have any ongoing serious infections.All my side effects from cancer treatment are mild, except for hair loss.My organs are working well.I have had an organ or stem cell transplant in the last 20 years.I can take care of myself but might not be able to do heavy physical work.I have not had major surgery or serious injury in the last 4 weeks.I currently have an active COVID-19 infection.I haven't had cancer treatment like chemo, hormone therapy, or radiation in the last 2 weeks.I haven't taken more than 10 mg of steroids daily in the last 4 weeks.I have had severe brain-related side effects from medication or have brain involvement due to my condition.
Research Study Groups:
This trial has the following groups:- Group 1: Combination Therapy Dose Escalation
- Group 2: ADA-011 Monotherapy Dose Escalation
- Group 3: ADA-011 Monotherapy Dose Expansion
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.
Is the Combination Therapy Dose Escalation procedure known to be innocuous for subjects?
"With limited clinical data of its efficacy and safety, our team at Power gave Combination Therapy Dose Escalation a score of 1 on the scale."
Answered by AI
Are new participants being welcomed into this trial presently?
"Indeed, the trial is open for recruitment according to data hosted on clinicaltrials.gov. This research study was initially posted on November 15th 2022 and has been modified most recently on January 6th 2023."
Answered by AI
What is the current size of this medical research study?
"Affirmative. Clinicaltrials.gov displays that this medical trial, initially advertised on November 15th 2022, is actively searching for participants to enrol in the study. Two sites are looking to enroll a combined 90 patients into the program."
Answered by AI
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