ADA-011 Monotherapy Dose Escalation for Solid Tumors

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
Florida Cancer Specialists, Orlando, FLSolid TumorsADA-011 - Drug
Eligibility
18+
All Sexes
What conditions do you have?
Select

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.

Eligible Conditions
  • Solid Tumors, Adult

Treatment Effectiveness

Effectiveness Progress

1 of 3

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1
ABBV-011
1
Part 3a: ABBV-706 + Budigalimab
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BJ-001

Study Objectives

2 Primary · 2 Secondary · Reporting Duration: 36 months

21 days (cycle 1)
Number of Dose-Limiting Toxicities (DLTs)
36 months
Number of Participants Positive for Anti-Drug Antibodies (ADA) After Treatment with ADA-011
Number of Participants Who Experienced an Adverse Event (AE)
Objective Response Rate (ORR) per Response Evaluation Criteria in Solid Tumors (RECIST) 1.1
Pharmacokinetic (PK) Profile of Participants Treated with ADA-011 (AUC)
Pharmacokinetic (PK) Profile of Participants Treated with ADA-011 (Cmax)

Trial Safety

Safety Progress

1 of 3

Similar Trials

1
ABBV-011
1
Part 3a: ABBV-706 + Budigalimab
1
BJ-001

Trial Design

3 Treatment Groups

ADA-011 Monotherapy Dose Escalation
1 of 3
ADA-011 Monotherapy Dose Expansion
1 of 3
Combination Therapy Dose Escalation
1 of 3

Experimental Treatment

90 Total Participants · 3 Treatment Groups

Primary Treatment: ADA-011 Monotherapy Dose Escalation · No Placebo Group · Phase 1

ADA-011 Monotherapy Dose Escalation
Drug
Experimental Group · 1 Intervention: ADA-011 · Intervention Types: Drug
ADA-011 Monotherapy Dose Expansion
Drug
Experimental Group · 1 Intervention: ADA-011 · Intervention Types: Drug
Combination Therapy Dose EscalationExperimental Group · 2 Interventions: ADA-011, PD(L)-1 inhibitor · Intervention Types: Drug, Drug

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: 36 months

Who is running the clinical trial?

Adanate, IncLead Sponsor

Eligibility Criteria

Age 18+ · All Participants · 4 Total Inclusion Criteria

Mark “Yes” if the following statements are true for you:
You have a solid tumor that has spread to other parts of the body and cannot be removed by surgery. The tumor has continued to grow even after receiving previous treatments, and there are no other known effective treatments.
References

Frequently Asked Questions

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." - Anonymous Online Contributor

Unverified Answer

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." - Anonymous Online Contributor

Unverified Answer

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." - Anonymous Online Contributor

Unverified Answer
Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

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