Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Calaspargase Pegol-mknl · 1 trial · 7 indications
Defined as any treatment-related grade \>= 3 non-hematological or hematological adverse events. The incidence of DLT at each dose level will be summarized using the proportion and exact binomial confidence interval. Dose-limiting toxicities will specifically be reported for the DLT evaluation period using the maximum tolerated dose (MTD)-evaluable population. The MTD will be identified using isotonic regression.
| Arm | Type | Description |
|---|---|---|
| Treatment (calaspargase pegol-mknl, cobimetinib) | EXPERIMENTAL | Patients receive calaspargase pegol-mknl IV over 1 hour on day 1 and cobimetinib PO QD on days 1-14. Treatment repeats every 21 days for up to 6 cycles in the absence of disease progression or unacceptable toxicity. Patients may also undergo a biopsy 14 days prior to starting therapybefore cycle 1, day 1 and again on day 14 of cycle 2, day 15 per the investigator's discretion, with an additional optional biopsy at the time of disease progression. |
| Name | Type | Description |
|---|---|---|
| Biopsy | PROCEDURE | Undergo biopsy |
| Calaspargase Pegol-mknl | DRUG | Given IV |
| Cobimetinib | DRUG | Given PO |
Inclusion Criteria: * Participant must provide written informed consent before any study-specific procedures or interventions are performed * Participants are \>= 18 years old at the time of informed consent. Both men and women of all races and ethnic groups will be included * Eastern Cooperative O...
Calaspargase Pegol-mknl is being studied for the treatment of locally advanced pancreatic adenocarcinoma. It is an investigational small molecule in Phase 1 clinical development, evaluated in combination with cobimetinib for patients with locally advanced or metastatic pancreatic cancer.
Calaspargase Pegol-mknl is being developed by Tango Therapeutics, Inc. (NASDAQ: TNGX). The company is conducting a Phase 1 clinical trial to evaluate the drug in patients with pancreatic cancer.
Calaspargase Pegol-mknl is in Phase 1 clinical development. It is an investigational drug, not yet approved by the FDA, and is being studied in an active but not recruiting clinical trial for pancreatic cancer.
Calaspargase Pegol-mknl is being evaluated in clinical trial NCT05034627, titled "Calaspargase Pegol-Mnkl and Cobimetinib for the Treatment of Locally Advanced or Metastatic Pancreatic Cancer." This Phase 1 study is active but not recruiting, with an enrollment of 15 participants in the United States.
Calaspargase Pegol-mknl is a specific formulation of calaspargase pegol, distinguished by the suffix "-mknl" which denotes its unique manufacturing process. In the clinical trial, it is referred to as Calaspargase Pegol-Mnkl, indicating the same drug entity.