Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
SRK-181 · 1 trial · 1 indication
Dose limiting toxicities (DLTs), as assessed by the Investigator, but not including toxicities clearly related to disease progression or intercurrent illness
Dose limiting toxicities (DLTs), as assessed by the Investigator, but not including toxicities clearly related to disease progression or intercurrent illness
| Arm | Type | Description |
|---|---|---|
| Part A1: Dose Escalation | EXPERIMENTAL | Part A1 determined the maximum tolerated dose (MTD) or maximum administered dose (MAD) of SRK-181 as a single agent and the recommended Phase 2 dose (RP2D) of SRK-181 as a single-agent. |
| Part A2: Dose Escalation | EXPERIMENTAL | Part A2 determined the MTD or MAD of SRK-181 in combination with anti-PD-(L)1 antibody therapy and the RP2D of SRK-181 in combination with anti-PD-(L)1 antibody therapy for use in Part B. |
| Part B: Dose Expansion | EXPERIMENTAL | In Part B, parallel cohorts of patients with Non-Small Cell Lung Cancer (NSCLC), Urothelial Carcinoma (UC), Cutaneous Melanoma (MEL), Clear Cell Renal Cell Carcinoma (ccRCC), Head and Neck Squamous Cell Carcinoma (HNSCC), or other advanced or metastatic solid tumor type that is not NSCLC, UC, MEL, or ccRCC were enrolled to confirm the tolerability of the RP2D of SRK-181 (determined in Part A2) and to evaluate the anti-tumor activity of SRK-181 in combination with an anti-PD-(L)1 antibody therapy. |
| Long Term Extension Phase (LTEP) | EXPERIMENTAL | Patients may continue treatment in a LTEP: * Part A1: Patients may continue treatment with SRK-181 as a single agent at the RP2D in the LTEP following 3 cycles of treatment with SRK-181 as a single agent in Part A1. * Part A2: Patients may continue treatment with SRK-181 at the RP2D in combination with anti-PD-(L)1 antibody therapy in the LTEP following 3 cycles of treatment with SRK-181 in combination with anti-PD-(L)1 antibody therapy in Part A2. * Part B: Patients may continue treatment with SRK-181 in combination with anti-PD-(L)1 antibody therapy following 9 cycles of treatment with SRK-181 in combination with anti-PD-(L)1 antibody therapy in Part B |
| Name | Type | Description |
|---|---|---|
| SRK-181 | BIOLOGICAL | anti-latent TGFβ1 monoclonal antibody |
| anti-PD-(L)1 antibody therapy | BIOLOGICAL | approved anti-PD-(L)1 antibody therapy for each tumor type |
Key Inclusion Criteria: * Patient has a histologically documented solid tumor that is metastatic or locally advanced, for which SoC therapy does not exist, has failed in the patient, or is not tolerated by the patient, or for which the patient has been assessed by the Investigator as not being a su...
Top 2 of 4 competitors
| Company | Ticker | Trials | Lead Phase | Drugs |
|---|---|---|---|---|
| GE Healthcare Technologies Inc. | GEHC | 1 | PHASE1 | GEH200520/GEH200521 |
| Ascentage Pharma Group International Unsponsored ADR | AAPG | 1 | PHASE1 | Olverembatinib |
SRK-181 is an investigational monoclonal antibody being studied for the treatment of locally advanced or metastatic solid tumors. It is being developed for use alone or in combination with anti-PD-(L)1 antibody therapy in patients with cancer. It has not been approved for any indication.
SRK-181 targets TGFβ1, a growth factor. By binding to TGFβ1, SRK-181 is designed to block its signaling, which is thought to contribute to immune evasion in tumors. This mechanism is being explored to overcome resistance to anti-PD-(L)1 therapies.
SRK-181 is being developed by Scholar Rock Holding Corporation, a biopharmaceutical company traded on the Nasdaq under the ticker SRRK. Scholar Rock is focused on discovering and developing therapies that target growth factor signaling.
SRK-181 is in Phase 1 clinical development. It is investigational and has not been approved by the FDA or any other regulatory agency. The Phase 1 trial has been completed.
SRK-181 has been evaluated in a Phase 1 clinical trial, NCT04291079, titled DRAGON. The trial studied SRK-181 alone or in combination with anti-PD-(L)1 antibody therapy in patients with locally advanced or metastatic solid tumors. It enrolled 112 patients in the United States and South Korea and is now completed.