Specific Advanced Solid Tumors
Conditions
Keywords
ACR-2316, WEE1, PKMYT1, Locally advanced, recurrent or metastatic solid tumors, P53
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 pharmacogenomics, and preliminary evaluation of anti-tumor activity.
Interventions
DRUGACR-2316
ACR-2316 is an experimental drug
Sponsors
Acrivon Therapeutics
Study design
Allocation
NON_RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
Dose escalation - Evaluable participants for dose limiting toxicity (DLT), maximum tolerated dose (MTD) determination for ACR-2316 administered per cohort 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.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Dose Escalation | Number of DLT events during the DLT observation period (up to 28 days) | To determine the MTD of ACR-2316. |
| Dose Expansion | RP2D supported by safety, PK, PD, and emerging clinical activity data through study completion, an average of 1 year. | To determine the RP2D of ACR-2316. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Dose Escalation | This will be evaluated through study completion, an average of 1 year. | To assess the safety and tolerability of ACR-2316. Safety will be assessed by the incidence of AEs characterized overall and by type, incidence, severity graded according to NCI CTCAE v5.0, seriousness, and relationship to study treatment. |
| Dose Expansion | Pharmacokinetic (PK) testing in Cycle 1, 2 & 3 (each cycle is up to 28 days). Predose and multiple time points after dose up to Cycle 3. | To assess Pharmacokinetics: maximum plasma drug concentration (Cmax). |
Countries
United States
Contacts
CONTACTMansoor R Mirza, MD
CONTACTJeanie Tang
Outcome results
None listed