Phase 1 Study of ACR-2316 in Specific Advanced Solid Tumors

Acrivon Therapeutics

Status and phase: Enrolling; Phase 1

Conditions: Specific Advanced Solid Tumors

Treatments: Drug: ACR-2316

Study type: Interventional

Funder types: Industry

Identifiers

NCT06667141

ACR-2316-101

Details and patient eligibility

About

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.

Full 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 pharmacogenomics, and preliminary evaluation of anti-tumor activity.

Enrollment: 100 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Inclusion Criteria:

1. Signed written informed consent.
2. Histologically or cytologically proven metastatic, recurrent or locally advanced selected solid tumors.
3. Must be willing to provide redacted pathology report.
4. Subjects should have received no more than 3 lines of systemic therapy for recurrent disease.
5. Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1 at trial entry and an estimated life expectancy of at least 3 months.
6. Disease must be measurable with at least 1 unidimensional measurable lesion by RECIST v1.1.
7. Adequate organ functions.
8. Must have progressed after prior line of treatment.

Exclusion Criteria (all participants):

1. Participants with known symptomatic brain metastases.
2. Participant had systemic therapy within 3 weeks prior to the first dose of study drug.
3. Participant had radiation therapy for curative intent within 4 weeks prior to the first dose of study drug.
4. Participant had palliative radiation therapy within 2 weeks prior to the first dose of study drug.
5. Women who are pregnant or lactating.

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Sequential Assignment

Masking: None (Open label)

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100 participants in 2 patient groups

Dose escalation

Experimental group

Description:

ACR-2316 will be administered using a 3-week or a 4-week schedule.

Treatment:

Drug: ACR-2316

Dose expansion

Experimental group

Description:

ACR-2316 will be administered using a 3-week or a 4-week schedule.

Treatment:

Drug: ACR-2316