Trial · NCT03104699

A Study of AGEN2034 in Advanced Tumors and Cervical Cancer

NCT03104699, Phase 1, Phase 2, Completed, Agenus Inc.; results first posted 2025-07-30

3 sourcestrials-2026-11-12-0.5.0

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ConductScience Library. A Study of AGEN2034 in Advanced Tumors and Cervical Cancer. Trials, record NCT03104699. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT03104699

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Trial

As registered on ClinicalTrials.gov, in the graph's capture of the registry.

Title: A Study of AGEN2034 in Advanced Tumors and Cervical Cancer
NCT number: NCT03104699
Status: Completed
Phases: Phase 1, Phase 2
Enrollment: 211 participants, actual
Lead sponsor: Agenus Inc.
Conditions: Advanced Cancer, Cervical Cancer
Interventions: AGEN2034
First posted: 2017-04-07
Last updated: 2025-07-30
Results first posted: 2025-07-30

Source ClinicalTrials.gov

Registered outcomes18

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

List	Outcome	Time frame	Description
Primary	Phase 1: Number of Participants Experiencing Dose-limiting Toxicities (DLTs) for Balstilimab	21 days	A DLT was defined as any treatment-related toxicity that was National Cancer Institute Common Terminology Criteria for Adverse Event Grade ≥3, confirmed by the safety monitoring committee to be relevant for the study drug treatment, and that occurred during the first 3 weeks of balstilimab treatment in the dose escalation portion of the study (DLT evaluation period).
Primary	Phase 1: Number of Participants Experiencing Treatment-emergent Adverse Events (TEAEs)	Up to 3 years	An adverse event (AE) was any untoward medical occurrence in a participant or clinical investigation participant administered a pharmaceutical product, which did not necessarily have a causal relationship with the treatment. TEAEs were AEs with onset dates during the on-treatment period, or the worsening of an event during the on-treatment period. A summary of all Serious Adverse Events and Other Adverse Events (nonserious), regardless of causality, is located in the 'Reported Adverse Events' Section.
Primary	Phase 2: Objective Response Rate (ORR) as Determined by an Independent Endpoint Review Committee (IERC)	Up to 3 years	ORR was defined as percentage of participants with a best overall response (BOR) of complete response (CR) or partial response (PR), as determined by an IERC per Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST 1.1). BOR was defined as the best response recorded from the start of the study treatment until the end of treatment. CR was defined as disappearance of all target lesions, and PR was defined as at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters.
Secondary	Phase 1: Receptor Occupancy of Circulating T Cells	4 hours after the first dose (Cycle 1 Day 1) and immediately prior to the second dose (Cycle 2 Day 1) (2-3 weeks/cycle)	The percentage of PD-1 receptor occupancy on circulating T cells was measured as an indication of target engagement. An increase in percent occupancy indicates a potential increase in drug effectiveness.
Secondary	Phase 1: Maximum Observed Concentration (Cmax) of Balstilimab	Day 1 (Pre-dose up to 24 hours post dose) of Cycle 1 and Cycle 2 (2-3 weeks/cycle) (up to 3 weeks)	Blood samples were collected for serum balstilimab concentration determinations. Results are reported as micrograms/milliliter (ug/mL).
Secondary	Phase 1: Area Under the Drug Concentration-time Curve From Time Zero to the Last Quantifiable Concentration (AUC0-last) of Balstilimab	Day 1 (Pre-dose up to 24 hours post dose) of Cycle 1 and Cycle 2 (2-3 weeks/cycle) (up to 3 weeks)	Blood samples were collected for serum balstilimab concentration determinations. Results are reported as hours\micrograms/milliliter (h\µg/mL).
Secondary	Phase 1: Number of Participants With Serum Anti-drug Antibodies (ADAs) for Balstilimab	Up to 2.5 years	Blood samples were collected for serum balstilimab ADA determination.
Secondary	Phase 2: Number of Participants Experiencing TEAEs	Up to 3 years	An AE was any untoward medical occurrence in a participant or clinical investigation participant administered a pharmaceutical product, which did not necessarily have a causal relationship with the treatment. TEAEs were AEs with onset dates during the on-treatment period, or the worsening of an event during the on-treatment period. A summary of all Serious Adverse Events and Other Adverse Events (nonserious) regardless of causality is located in the 'Reported Adverse Events' Section.
Secondary	Phase 2: Cmax of Balstilimab	Day 1 (Pre-dose up to 24 hours post dose) of Cycle 1 and Cycle 2 (2 weeks/cycle) (up to 2 weeks)	Blood samples were collected for serum balstilimab concentration determinations. Results are reported in μg/mL.
Secondary	Phase 2: AUC0-last of Balstilimab	Day 1 (Pre-dose up to 24 hours post dose) of Cycle 1 and Cycle 2 (2 weeks/cycle) (up to 2 weeks)	Blood samples were collected for serum balstilimab concentration determinations. Results are reported in day\*μg/mL.

1 to 10 of 18Source ClinicalTrials.gov

See all 18 registered outcomes

Outcomes18

Each outcome the trial posted results for, in ClinicalTrials.gov's words.

Type	Outcome	Time frame	Population	Units	Measured as
PRIMARY	Phase 1: Number of Participants Experiencing Dose-limiting Toxicities (DLTs) for Balstilimab	21 days	DLT Analysis Set: all participants who were enrolled for DLT evaluation (excluding participants enrolled to backfill cohorts) and either received all balstilimab administrations or stopped treatment due to a DLT during the DLT evaluation period. Here, 'Overall Number of Participants Analyzed' signifies those participants who were evaluable for this outcome measure.	Participants	COUNT_OF_PARTICIPANTS
PRIMARY	Phase 1: Number of Participants Experiencing Treatment-emergent Adverse Events (TEAEs)	Up to 3 years	Safety Analysis Set: all participants who received at least 1 dose of balstilimab.	Participants	COUNT_OF_PARTICIPANTS
PRIMARY	Phase 2: Objective Response Rate (ORR) as Determined by an Independent Endpoint Review Committee (IERC)	Up to 3 years	Intent-to-Treat Efficacy Analysis Set: all participants who received ≥1 dose of balstilimab with measurable disease at baseline (per IERC).	percentage of participants	NUMBER
SECONDARY	Phase 1: Receptor Occupancy of Circulating T Cells	4 hours after the first dose (Cycle 1 Day 1) and immediately prior to the second dose (Cycle 2 Day 1) (2-3 weeks/cycle)	Receptor Occupancy Analysis Set: all participants who completed ≥1 balstilimab infusion, with adequate measurements of PD-1 receptor occupancy on circulating T cells. Here, 'Number Analyzed' signifies those participants who were evaluable for this outcome measure at the specified time points.	percent occupancy	MEAN
SECONDARY	Phase 1: Maximum Observed Concentration (Cmax) of Balstilimab	Day 1 (Pre-dose up to 24 hours post dose) of Cycle 1 and Cycle 2 (2-3 weeks/cycle) (up to 3 weeks)	Pharmacokinetic Analysis Set: all participants who completed ≥1 balstilimab infusion of study drug and who had sufficient evaluable drug concentration measurements prior to and after treatment. Here, 'Number Analyzed' signifies those participants who were evaluable for this outcome measure at the specified time points.	ug/mL	GEOMETRIC_MEAN
SECONDARY	Phase 1: Area Under the Drug Concentration-time Curve From Time Zero to the Last Quantifiable Concentration (AUC0-last) of Balstilimab	Day 1 (Pre-dose up to 24 hours post dose) of Cycle 1 and Cycle 2 (2-3 weeks/cycle) (up to 3 weeks)	Pharmacokinetic Analysis Set: all participants who completed ≥1 balstilimab infusion and who had sufficient evaluable drug concentration measurements prior to and after treatment. Here, 'Number Analyzed' signifies those participants who were evaluable for this outcome measure at the specified time points.	h*µg/mL	GEOMETRIC_MEAN
SECONDARY	Phase 1: Number of Participants With Serum Anti-drug Antibodies (ADAs) for Balstilimab	Up to 2.5 years	Safety Analysis Set: all participants who received at least 1 dose of balstilimab.	Participants	COUNT_OF_PARTICIPANTS
SECONDARY	Phase 2: Number of Participants Experiencing TEAEs	Up to 3 years	Safety Analysis Set: all participants who received at least 1 dose of balstilimab.	Participants	COUNT_OF_PARTICIPANTS
SECONDARY	Phase 2: Cmax of Balstilimab	Day 1 (Pre-dose up to 24 hours post dose) of Cycle 1 and Cycle 2 (2 weeks/cycle) (up to 2 weeks)	Pharmacokinetic Analysis Set: all participants who completed ≥1 balstilimab infusion and who had sufficient evaluable drug concentration measurements prior to and after treatment. Here, 'Number Analyzed' signifies those participants who were evaluable for this outcome measure at the specified time points.	μg/mL	GEOMETRIC_MEAN
SECONDARY	Phase 2: AUC0-last of Balstilimab	Day 1 (Pre-dose up to 24 hours post dose) of Cycle 1 and Cycle 2 (2 weeks/cycle) (up to 2 weeks)	Pharmacokinetic Analysis Set: all participants who completed ≥1 balstilimab infusion and who had sufficient evaluable drug concentration measurements prior to and after treatment. Here, 'Number Analyzed' signifies those participants who were evaluable for this outcome measure at the specified time points.	day*μg/mL	GEOMETRIC_MEAN

1 to 10 of 18Source ClinicalTrials.gov

See all 18 outcomes

Results by group57

Each measurement the trial posted, group by group, in the words and numbers it posted.

Outcome	Group	Value	Units
Phase 1: Number of Participants Experiencing Dose-limiting Toxicities (DLTs) for Balstilimab	Phase 1: Balstilimab Dose 1	0	Participants
Phase 1: Number of Participants Experiencing Dose-limiting Toxicities (DLTs) for Balstilimab	Phase 1: Balstilimab Dose 2	0	Participants
Phase 1: Number of Participants Experiencing Dose-limiting Toxicities (DLTs) for Balstilimab	Phase 1: Balstilimab Dose 3	0	Participants
Phase 1: Number of Participants Experiencing Dose-limiting Toxicities (DLTs) for Balstilimab	Phase 1: Balstilimab Dose 4	0	Participants
Phase 1: Number of Participants Experiencing Dose-limiting Toxicities (DLTs) for Balstilimab	Phase 1: Balstilimab Dose 5	0	Participants
Phase 1: Number of Participants Experiencing Treatment-emergent Adverse Events (TEAEs)	Phase 1: Balstilimab Dose 1	10	Participants
Phase 1: Number of Participants Experiencing Treatment-emergent Adverse Events (TEAEs)	Phase 1: Balstilimab Dose 2	10	Participants
Phase 1: Number of Participants Experiencing Treatment-emergent Adverse Events (TEAEs)	Phase 1: Balstilimab Dose 3	10	Participants
Phase 1: Number of Participants Experiencing Treatment-emergent Adverse Events (TEAEs)	Phase 1: Balstilimab Dose 4	10	Participants
Phase 1: Number of Participants Experiencing Treatment-emergent Adverse Events (TEAEs)	Phase 1: Balstilimab Dose 5	10	Participants

1 to 10 of 57Source ClinicalTrials.gov

See all 57 results by group

Participant flow48

How many started, completed or left each group, period by period.

Period	Milestone	Group	Participants
Phase 1: Dose Escalation	STARTED	Phase 1: Balstilimab Dose 1	10
Phase 1: Dose Escalation	STARTED	Phase 1: Balstilimab Dose 2	10
Phase 1: Dose Escalation	STARTED	Phase 1: Balstilimab Dose 3	10
Phase 1: Dose Escalation	STARTED	Phase 1: Balstilimab Dose 4	10
Phase 1: Dose Escalation	STARTED	Phase 1: Balstilimab Dose 5	10
Phase 1: Dose Escalation	STARTED	Phase 2: Balstilimab Recommended Phase 2 Dose	0
Phase 1: Dose Escalation	Received at Least 1 Dose of Study Drug	Phase 1: Balstilimab Dose 1	10
Phase 1: Dose Escalation	Received at Least 1 Dose of Study Drug	Phase 1: Balstilimab Dose 2	10
Phase 1: Dose Escalation	Received at Least 1 Dose of Study Drug	Phase 1: Balstilimab Dose 3	10
Phase 1: Dose Escalation	Received at Least 1 Dose of Study Drug	Phase 1: Balstilimab Dose 4	10

1 to 10 of 48Source ClinicalTrials.gov

See all 48 participant flow

Adverse events1,692

Each adverse event the trial posted, group by group: the participants affected out of those at risk.

Type	Event	Organ system	Group	Affected	At risk
other	Nausea	Gastrointestinal disorders	Phase 1: Balstilimab Dose 1	6	10
other	Nausea	Gastrointestinal disorders	Phase 1: Balstilimab Dose 2	3	10
other	Nausea	Gastrointestinal disorders	Phase 1: Balstilimab Dose 3	4	10
other	Nausea	Gastrointestinal disorders	Phase 1: Balstilimab Dose 4	5	10
other	Nausea	Gastrointestinal disorders	Phase 1: Balstilimab Dose 5	3	10
other	Nausea	Gastrointestinal disorders	Phase 2: Balstilimab Recommended Phase 2 Dose	47	161
other	Constipation	Gastrointestinal disorders	Phase 1: Balstilimab Dose 1	4	10
other	Constipation	Gastrointestinal disorders	Phase 1: Balstilimab Dose 2	2	10
other	Constipation	Gastrointestinal disorders	Phase 1: Balstilimab Dose 3	2	10
other	Constipation	Gastrointestinal disorders	Phase 1: Balstilimab Dose 4	1	10

1 to 10 of 1,692Source ClinicalTrials.gov

See all 1,692 adverse events

Adverse event totals18

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	Phase 1: Balstilimab Dose 1	6	10
Total, all-cause mortality	Phase 1: Balstilimab Dose 2	3	10
Total, all-cause mortality	Phase 1: Balstilimab Dose 3	0	10
Total, all-cause mortality	Phase 1: Balstilimab Dose 4	1	10
Total, all-cause mortality	Phase 1: Balstilimab Dose 5	1	10
Total, all-cause mortality	Phase 2: Balstilimab Recommended Phase 2 Dose	108	161
Total, other adverse events	Phase 1: Balstilimab Dose 1	10	10
Total, other adverse events	Phase 1: Balstilimab Dose 2	10	10
Total, other adverse events	Phase 1: Balstilimab Dose 3	10	10
Total, other adverse events	Phase 1: Balstilimab Dose 4	10	10

1 to 10 of 18Source ClinicalTrials.gov

See all 18 adverse event totals

Papers0

The papers the trial lists on ClinicalTrials.gov.

None in this release.

Grants0

The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.

None in this release.

Trial comparisons0

Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.

None in this release.

Tests0

The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.

None in this release.

Data dates

The day each source was copied for this release.

ClinicalTrials.gov: 2026-11-12; ClinicalTrials.gov
Results, from AACT: 2026-03-23; AACT
NIH grant links: 2026-11-13; NIH RePORTER

Sources 3

ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
ClinicalTrials.govNo license stated
NIH RePORTER's clinical studies and project filesPublic domain

Each source's terms

ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
ClinicalTrials.govnone stated
NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)

ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.

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