Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
ARV-6723 · 1 trial · 1 indication
Number of participants within a dose escalation cohort with adverse events (AEs) meeting protocol defined dose limiting toxicities during cycle 1 (21 days).
AEs as characterized by type, frequency, severity (as graded by National Cancer Institute Common Terminology Criteria for Adverse Events \[NCI CTCAE\]), timing, seriousness, and relationship to study intervention as a measure of safety and tolerability.
AEs as characterized by type, frequency, severity (as graded by National Cancer Institute Common Terminology Criteria for Adverse Events \[NCI CTCAE\]), timing, seriousness, and relationship to study intervention as a measure of safety and tolerability.
ORR is defined as the proportion of participants reaching a confirmed complete response (CR) or partial response (PR) to the study treatment based on investigator assessment using RECIST 1.1 criteria.
ORR is defined as the proportion of participants reaching a confirmed complete response (CR) or partial response (PR) to the study treatment based on investigator assessment using RECIST 1.1 criteria.
| Arm | Type | Description |
|---|---|---|
| Part A1a: Phase 1 Monotherapy dose escalation | EXPERIMENTAL | Participants will receive the assigned dose of ARV-6723 orally once daily (QD) in tablet form, under fasted conditions in 21-day cycles. Treatment will continue at the investigator's discretion until disease progression, unacceptable toxicity, withdrawal of consent or death. |
| Part A1b: Phase 1 Combination therapy dose escalation | EXPERIMENTAL | Participants will receive the assigned dose of ARV-6723 orally QD in tablet form, under fasted conditions along with pembrolizumab by intravenous (IV) infusion or subcutaneous (SQ) injection at fixed dose once every 3 weeks (Q3W) in 21-day cycles. Treatment will continue at the investigator's discretion until disease progression, unacceptable toxicity, withdrawal of consent or death. |
| Part A2b: Phase 1 Monotherapy dose optimization | EXPERIMENTAL | Participants will receive the assigned dose of ARV-6723, based on Phase A1a, orally QD in tablet form, under fasted conditions in 21-day cycles. Treatment will continue at the investigator's discretion until disease progression, unacceptable toxicity, withdrawal of consent or death. |
| Part A2b: Phase 1 Combination therapy dose optimization | EXPERIMENTAL | Participants will receive the assigned dose of ARV-6723, based on Phase A1b orally QD in tablet form, under fasted conditions along with pembrolizumab IV infusion or SQ injection at fixed dose Q3W in 21-day cycles. Treatment will continue at the investigator's discretion until disease progression, unacceptable toxicity, withdrawal of consent or death. |
| Part B: Phase 2 Monotherapy dose expansion | EXPERIMENTAL | Participants will receive the assigned dose of ARV-6723, selected based on Part A in 21-day cycles. Treatment will continue at the investigator's discretion until disease progression, unacceptable toxicity, withdrawal of consent or death. |
| Part B: Phase 2 Combination dose expansion | EXPERIMENTAL | Participants will receive the assigned dose of ARV-6723, selected based on Part A in combination with pembrolizumab by IV infusion or SQ injection n 21-day cycles. Treatment will continue at the investigator's discretion until disease progression, unacceptable toxicity, withdrawal of consent or death. |
| Part B: Phase 2 Standard of care (SOC) | EXPERIMENTAL | Participants will receive SOC treatment regimens based on investigators choice and the tumor indications. Treatment will continue at the investigator's discretion until disease progression, unacceptable toxicity, withdrawal of consent or death. |
| Name | Type | Description |
|---|---|---|
| ARV-6723 | DRUG | Oral daily dose of ARV-6723 at an assigned dose. |
| Pembrolizumab | DRUG | IV infusion or SQ injection Q3W at an assigned dose. |
| SOC | DRUG | Investigator's choice of SOC drugs. |
Inclusion Criteria: Part A1 dose escalation and A2 dose optimization: Participants must meet all of the following criteria: * Have a histologic or cytologic diagnosis of unresectable or metastatic solid tumor malignancy. * Have previously received at least one prior therapy targeting programmed ce...
| Company | Ticker | Trials | Lead Phase | Drugs |
|---|---|---|---|---|
| Merck & Co., Inc. | MRK | 2 | PHASE2 | pembrolizumab |
| Incyte Corporation | INCY | 1 | PHASE2 | Chemotherapy, Retifanlimab |
| Iovance Biotherapeutics Inc | IOVA | 2 | PHASE2 | E7 TCR-T cells, Aldesleukin |
| Novartis AG Sponsored ADR | NVS | 1 | PHASE1 | KFA115, pembrolizumab |
| AstraZeneca PLC | AZN | 1 | - | Trastuzumab deruxtecan |
ARV-6723 is an investigational small molecule being studied for the treatment of advanced solid tumors. It is currently in Phase 1 clinical development, where it is being evaluated alone and in combination with pembrolizumab in participants with advanced solid tumors.
ARV-6723 targets HPK1, a kinase involved in T cell signaling. By targeting HPK1, the drug is designed to modulate immune responses, which may have therapeutic potential in oncology. This mechanism is being explored in the context of advanced solid tumors.
ARV-6723 is being developed by Arvinas, Inc., a biopharmaceutical company traded on NASDAQ under the ticker ARVN. The company is conducting a Phase 1 clinical trial to evaluate the drug in patients with advanced solid tumors.
ARV-6723 is in Phase 1 clinical development. It is an investigational drug, meaning it has not been approved by regulatory authorities. The ongoing Phase 1 trial is recruiting participants to assess the safety and efficacy of ARV-6723 in advanced solid tumors.
ARV-6723 is being studied in a Phase 1 clinical trial with the identifier NCT07749586. This trial evaluates ARV-6723 alone and in combination with pembrolizumab in participants with advanced solid tumors. The trial is recruiting in the United States and has an enrollment target of 499 participants.
ARV-6723 is a distinct investigational drug developed by Arvinas, Inc. It is not known to be the same as any other marketed or investigational drug. Its unique mechanism targets HPK1, and it is being studied specifically for advanced solid tumors.