Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Taletrectinib · 4 trials · 3 indications
Measure Description: Defined as the time from the date of randomization until the date of disease recurrence or death (by any cause in the absence of recurrence) by investigator's assessment.
Progression-Free-Survival, The time between the beginning of treatment and the occurrence of disease progression or death. Assessed by the blinded Independent Review Committee (BIRC), per RECIST v1.1
Confirmed ORR according to Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 assessed by an independent radiology review committee (IRC)
| Arm | Type | Description |
|---|---|---|
| Taletrectinib Active Arm | ACTIVE_COMPARATOR | Active Arm |
| Placebo Arm | PLACEBO_COMPARATOR | Placebo Arm |
| Taletrectinib | EXPERIMENTAL | 97 ROS1-Positive Locally Advanced or Metastatic Non-Small Cell Lung Cancer patients will be enrolled in Arm A and treated with talerectinib |
| Crizotinib | ACTIVE_COMPARATOR | 97 ROS1-Positive Locally Advanced or Metastatic Non-Small Cell Lung Cancer patients will be enrolled in Arm B and treated with Crizotinib |
| Taletrectinib 600 mg single dose (Part 1, Treatment A) | EXPERIMENTAL | A single oral dose of taletrectinib 600 mg 2 hours after a meal (2-hour fast),on the morning of Part 1, Treatment A Day 1. |
| Famotidine 40mg + taletrectinib 600mg single dose (Part 1,Treatment B). | EXPERIMENTAL | A single oral dose of famotidine 40mg administered with a meal on the morning of Part 1, Treatment B Day 1, and taletrectinib 600mg administered orally 2 hours later (2-hour fast). |
| Famotidine 20mg + taletrectinib 600mg + famotidine 20mg single dose (Part 1, Treatment C) | EXPERIMENTAL | A single oral dose of famotidine 20mg administered to each participant on the night of Day 1. On the morning of Day 2, 8 hours after the prior dose of famotidine, participants will eat a meal and then be administered taletrectinib 600mg after a 2-hour fast; a final single oral dose of famotidine 20mg will be administered 2 hours after the dose of taletrectinib. |
| Taletrectinib 400mg single dose (Part 2,Treatment A) | EXPERIMENTAL | A single oral dose of taletrectinib 400 mg dosed within 30 min (no longer than 1 hour) after a meal,on the morning of Part 2 Treatment A Day 1. |
| Famotidine 40mg + taletrectinib 400mg single dose (Or Part 2,Treatment B). | EXPERIMENTAL | A single oral dose of 40 mg famotidine and 2 hours later, taletrectinib 400 mg will be dosed within 30 min (no longer than 1 hour) after a meal. |
| Famotidine 20mg + taletrectinib 400mg + famotidine 20mg single dose (Or Part 2, Treatment C) | EXPERIMENTAL | A single oral dose of 20 mg famotidine. On the morning of Day 2 of Part 2 Treatment C, taletrectinib 400 mg should be administered within 30 min and no longer than 1 hour after a meal, 10 hours after the famotidine dose from the prior evening; a final oral dose of 20 mg famotidine will be administrated 2 hours later. |
| Name | Type | Description |
|---|---|---|
| Taletrectinib | DRUG | Intervention Label: Taletrectinib Intervention Name: Taletrectinib Dosage Formulation: Capsule Unit Dose Strength(s): 200 mg Dosage Level (s): 400 mg QD Route of Administration: Oral Use: Experimental IMP and NIMP/AxMP : IMP Former Name(s) or Alias(es): AB-106. |
| Placebo | DRUG | Intervention Label: Placebo Intervention Name: Placebo Type: Drug Dosage Formulation: Capsule Unit Dose Strength(s): 200 mg Dosage Level(s): 400 mg QD Route of Administration: Oral Use: Placebo Comparator IMP and NIMP/AxMP: IMP Former Name(s) or Alias(es): Placebo |
| Crizotinib | DRUG | Approximately 194 ROS-1TKI- naïve ROS1+NSCLC patients will be randomized in a 1:1 ration to one of 2 study arms: Arm A: Taletrectinib monotherapy at 600 mg once daily (QD); Arm B: Crizotinib monotherapy at 250 mg twice daily (BID). Each cycle duration will be 28 days. Participants will be treated until they experience progressive disease (PD) assessed by the blinded Independent Review Committee (BIRC), intolerable toxicity, or another discontinuation criterion is met. Crossover from control group (crizotinib) to taletrectinib is also permitted, at the Investigator's discretion with the Sponsor's approval, for qualifying participants who have experienced objective progression confirmed by the BIRC. |
| Taletrectinib, Famotidine | DRUG | A single oral dose of famotidine 40mg administered with a meal on the morning of Part 1, Treatment B Day 1, and taletrectinib 600mg administered orally 2 hours later (2-hour fast). |
| Taletrectinib,Famotidine | DRUG | A single oral dose of 20 mg famotidine. On the morning of Day 2 of Part 2 Treatment C, taletrectinib 400 mg should be administered within 30 min and no longer than 1 hour after a meal, 10 hours after the famotidine dose from the prior evening; a final oral dose of 20 mg famotidine will be administrated 2 hours later. |
Inclusion Criteria: 1. Histologically confirmed stage IB, II, or IIIA NSCLC (AJCC 9th edition) based on pathological staging. 2. Documented ROS1 rearrangement in primary tumor by a validated local assay performed in CLIA-certified or locally equivalent diagnostic laboratories. 3. Adequate tissue is...
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Taletrectinib is an investigational small molecule being developed for Non-small Cell Lung Cancer (NSCLC). It is also being studied in healthy adult participants for pharmacokinetic research. The drug is currently in clinical development and has not been approved by the FDA.
Taletrectinib targets NTRK1, NTRK2, NTRK3, and ROS1. It is an inhibitor of these molecular targets, which are involved in certain types of cancer. By inhibiting these targets, the drug aims to interfere with cancer cell growth and survival.
Taletrectinib is being developed by Nuvation Bio Inc., a biopharmaceutical company. The company's stock is traded under the ticker symbol NUVB. Nuvation Bio is conducting clinical trials to evaluate the safety and efficacy of Taletrectinib in patients with Non-small Cell Lung Cancer.
Taletrectinib is in Phase 1 clinical development. However, the company is also conducting Phase 2 and Phase 3 trials for the drug. The drug has received FDA designations including Breakthrough Therapy, Priority Review, and Orphan Drug status, but it remains investigational.
Taletrectinib is being studied in several clinical trials. NCT04919811 is a Phase 2 global study in ROS1 positive NSCLC. NCT06564324 is a Phase 3 study comparing Taletrectinib with standard therapy in ROS1 positive NSCLC. NCT07154706 is a Phase 3 adjuvant therapy study, and NCT07742384 is a Phase 1 pharmacokinetic study in healthy participants.
Taletrectinib is a unique investigational drug and is not known to be the same as any other approved medication. It is being developed specifically for cancers with ROS1 or NTRK alterations. No alternative names for Taletrectinib have been reported in clinical trial registrations.