Subjects With Metastatic or Locally Advanced Solid Tumors, and Expansion Into Select Solid Tumors (Cervical)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT03495882|
Recruitment Status : Recruiting
First Posted : April 12, 2018
Last Update Posted : July 24, 2018
|Condition or disease||Intervention/treatment||Phase|
|Cervical Cancer||Drug: AGEN1884 + AGEN2034||Phase 1 Phase 2|
This is a Phase 1/2, open-label, multi-arm study, of AGEN1884 in combination with AGEN2034 in subjects with advanced solid tumors including cervical cancer. AGEN2034 is a novel, fully human monoclonal immunoglobulin G4 (IgG4) antibody, designed to block program cell death-1 (PD-1). AGEN1884 is a novel, fully human monoclonal immunoglobulin G1 (IgG1) antibody, designed to block cytotoxic T lymphocyte antigen-4 (CTLA-4).
The study consists of two phases:
- Phase 1: Dose escalation
- Phase 2: Expansion in Select Tumors - CERVICAL
Phase 1: Part A - Dose Escalation:
The study will consist initially of a 3+3 dose escalation that will evaluate different combination dose levels of AGEN1884 and AGEN2034 in subjects with advanced / refractory solid tumors.
Phase 2: Expansion in Select Tumors
To further characterize safety and efficacy, the following expansion cohort will be enrolled:
Part B - recurrent, unresectable, or metastatic cervical cancer In Phase 2, the selected CDL of AGEN2034 and AGEN1884, established in Part A, will be administered for a maximum of 2 years or until confirmed progression, unacceptable toxicity, or any criterion for stopping the study drugs or withdrawal from the trial occurs.
For the Phase 2 portion of the study, an Independent Data Management Committee (IDMC) will be established to evaluate safety and efficacy and an Independent Endpoint Review Committee (IERC) will be established to adjudicate tumor response.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||60 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Phase 1/2 Safety, Tolerability, Pharmacokinetics, Biological, and Clinical Activity of AGEN1884 in Combination With AGEN2034 in Subjects With Metastatic or Locally Advanced Solid Tumors, and Expansion Into Select Solid Tumors (Cervical)|
|Actual Study Start Date :||December 18, 2017|
|Estimated Primary Completion Date :||March 4, 2022|
|Estimated Study Completion Date :||March 4, 2023|
Experimental: AGEN1884 + AGEN2034
AGEN1884 in combination with AGEN2034 in subjects with Subjects with Metastatic or Locally Advanced Solid Tumors, and Expansion into Select Solid Tumors (cervical)
Drug: AGEN1884 + AGEN2034
AGEN1884 + AGEN2034 according to protocol design
- Assess the safety and tolerability of AGEN1884 in combination with AGEN2034 [ Time Frame: From time of time of first dose until the end of follow-up (up to approximately 60 Weeks). ] ]Percentage of participants experiencing any unfavorable and unintended sign, symptom, disease, or worsening of pre-existing condition temporally associated with study therapy and irrespective of causality to study therapy.
- Overall Response Rate (ORR) per RECIST 1.1 [ Time Frame: Up to approximately 2 years ]ORR is the proportion of the participants who achieve complete response (CR) or partial response (PR) per RECIST 1.1 by Blinded independent central review (BICR)
- Duration Of Response (DOR) [ Time Frame: Up to approximately 2 years ]DOR is the time from first documented evidence of CR or PR per RECIST 1.1 by Blinded independent central review (BICR) until disease progression per RECIST 1.1 by BICR or death
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03495882
|Contact: Sara Coulteremail@example.com|
|Linear Clinical Research||Recruiting|
|Contact: Tarek Meniawy firstname.lastname@example.org|
|Contact 1300 546 327|
|Icon Cancer Care South Brisbane||Recruiting|
|South Brisbane, Australia|
|Contact: Mr Adam Stoneley +61 7 3737 4558 email@example.com|
|South Brisbane, Australia|
|Contact: Catherine Shannon, MD firstname.lastname@example.org|
|Contact +61 7 3163 7689|
|Scientia Clinical Research||Recruiting|
|Contact: James Kuo, MD +61 2 9382 5800 email@example.com|
|Principal Investigator:||Dr Jermaine Coward, MD||Icon Cancer Care South Brisbane|