Clinical trial NCT06667141: Phase 1 Study of ACR-2316 in Specific Advanced Solid Tumors
Official title: ACR-2316-101: Phase 1 Study of ACR-2316 in Subjects With Advanced Solid Tumors
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE1
Conditions: Specific Advanced Solid Tumors
Keywords: ACR-2316
WEE1
PKMYT1
Locally advanced, recurrent or metastatic solid tumors
Lead sponsor: Acrivon Therapeutics
Sponsor class: INDUSTRY
First posted: 2024-10-31
Enrollment: 90
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SEQUENTIAL
Intervention model description: Dose escalation - Evaluable participants for dose limiting toxicity (DLT), maximum tolerated dose (MTD) determination for ACR-2316 administered per schedule A.

Dose expansion - participants with certain tumor types will be randomized 1:1 to receive1 of the 2 dose levels that will be selected for the determination of RP2D.
Primary purpose: TREATMENT

Brief summary: This is a first in-human, Open-label Phase 1 study to assess the safety of ACR-2316 for the treatment of subjects with specific, histologically confirmed, locally advanced, recurrent or metastatic solid tumors.

Detailed description: The Phase 1 monotherapy clinical trial for ACR-2316 is designed to assess the safety and tolerability of ACR-2316. Additional objectives include the determination of the maximal tolerated dose and recommended Phase 2 monotherapy dose, characterization of the pharmacokinetic profile, and preliminary evaluation of anti-tumor activity.

Eligibility criteria: Inclusion Criteria:

1. Signed written informed consent.
2. Histologically or cytologically proven metastatic, recurrent or locally advanced selected solid tumors.
3. Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1 at trial entry and an estimated life expectancy of at least 3 months.
4. Disease must be measurable with at least 1 unidimensional measurable lesion by RECIST v1.1.
5. Adequate organ functions.
6. Must have progressed after prior line of treatment.

Exclusion Criteria (all participants):

1. Participants with known symptomatic brain metastases.
2. Participant had systemic therapy or radiation therapy within 2 weeks prior to the first dose of study drug.
3. Women who are pregnant or lactating.

Primary outcomes:
measure: Dose Escalation
timeFrame: DLTs will be evaluated from first dose of ACR-2316 to day 21 for each subject in each dose level.
measure: Dose Expansion
timeFrame: The RP2D will be evaluated by the incidence of DLT events per dose level through study completion, an average of 1 year.
Secondary outcomes:
measure: Dose Escalation
timeFrame: This will be evaluated through study completion, an average of 1 year.
measure: Dose Escalation
timeFrame: Pharmacokinetic (PK) testing in Cycle 1, 2 & 3 (each cycle is 21 days). Predose and multiple time points after dose up to Cycle 3.
measure: Dose Escalation
timeFrame: Pharmacokinetic (PK) testing in Cycle 1, 2 & 3 (each cycle is 21 days). Predose and multiple time points after dose up to Cycle 3.
measure: Dose Escalation
timeFrame: Pharmacokinetic (PK) testing in Cycle 1, 2 & 3 (each cycle is 21 days). Predose and multiple time points after dose up to Cycle 3.
measure: Dose Escalation
timeFrame: Pharmacokinetic (PK) testing in Cycle 1, 2 & 3 (each cycle is 21 days). Predose and multiple time points after dose up to Cycle 3.
measure: Dose Escalation
timeFrame: Pharmacokinetic (PK) testing in Cycle 1, 2 & 3 (each cycle is 21 days). Predose and multiple time points after dose up to Cycle 3.
measure: Dose Escalation
timeFrame: Pharmacokinetic (PK) testing in Cycle 1, 2 & 3 (each cycle is 21 days). Predose and multiple time points after dose up to Cycle 3.
measure: Dose Escalation
timeFrame: Pharmacokinetic (PK) testing in Cycle 1, 2 & 3 (each cycle is 21 days). Predose and multiple time points after dose up to Cycle 3.
measure: Dose Escalation
timeFrame: Pharmacokinetic (PK) testing in Cycle 1, 2 & 3 (each cycle is 21 days). Predose and multiple time points after dose up to Cycle 3.
measure: Dose Escalation
timeFrame: Pharmacokinetic (PK) testing in Cycle 1, 2 & 3 (each cycle is 21 days). Predose and multiple time points after dose up to Cycle 3.
measure: Dose Expansion
timeFrame: This will be evaluated through study completion, an average of 1 year.
measure: Dose Expansion
timeFrame: Pharmacokinetic (PK) testing in Cycle 1, 2 & 3 (each cycle is 21 days). Predose and multiple time points after dose up to Cycle 3.
measure: Dose Expansion
timeFrame: Pharmacokinetic (PK) testing in Cycle 1, 2 & 3 (each cycle is 21 days). Predose and multiple time points after dose up to Cycle 3.
measure: Dose Expansion
timeFrame: Pharmacokinetic (PK) testing in Cycle 1, 2 & 3 (each cycle is 21 days). Predose and multiple time points after dose up to Cycle 3.
measure: Dose Expansion
timeFrame: Pharmacokinetic (PK) testing in Cycle 1, 2 & 3 (each cycle is 21 days). Predose and multiple time points after dose up to Cycle 3.
measure: Dose Expansion
timeFrame: Pharmacokinetic (PK) testing in Cycle 1, 2 & 3 (each cycle is 21 days). Predose and multiple time points after dose up to Cycle 3.
measure: Dose Expansion
timeFrame: Pharmacokinetic (PK) testing in Cycle 1, 2 & 3 (each cycle is 21 days). Predose and multiple time points after dose up to Cycle 3.
measure: Dose Expansion
timeFrame: Pharmacokinetic (PK) testing in Cycle 1, 2 & 3 (each cycle is 21 days). Predose and multiple time points after dose up to Cycle 3.
measure: Dose Expansion
timeFrame: Pharmacokinetic (PK) testing in Cycle 1, 2 & 3 (each cycle is 21 days). Predose and multiple time points after dose up to Cycle 3.
measure: Dose Expansion
timeFrame: Pharmacokinetic (PK) testing in Cycle 1, 2 & 3 (each cycle is 21 days). Predose and multiple time points after dose up to Cycle 3.
Other outcomes:
Locations:
city: Beverly Hills
country: United States
facility: Precision NextGen Oncology & Research Center
state: California
city: Sarasota
country: United States
facility: Florida Cancer Institute
state: Florida
city: Ann Arbor
country: United States
facility: University of Michigan
state: Michigan
city: Bronx
country: United States
facility: Montefiore Medical Centre
state: New York
city: Huntersville
country: United States
facility: Carolina BioOncology Institute
state: North Carolina
city: Providence
country: United States
facility: Rhode Island Hospital
state: Rhode Island
city: Franklin
country: United States
facility: Tennesse Oncology
state: Tennessee
city: Houston
country: United States
facility: The University of Texas MD Anderson Cancer Center
state: Texas
city: San Antonio
country: United States
facility: NEXT Oncology
state: Texas
city: Fairfax
country: United States
facility: Next Virginia
state: Virginia
Study officials:
References: