Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Also known as utidelone injection, Utidelone Capsule
Utidelone · 5 trials · 8 indications
dose limiting toxicity (DLT), defined as any toxicity meeting the criteria outlined in the protocol during Cycle 1 in a 21-days cycle
From the first dosing until death (from any cause), follow-up began after the end of treatment
Reflected by percentage of tumor size reduction or regression, assessed by imaging techniques and expressed as Objective Response Rate (ORR) ORR is defined as the proportion of patients with a best overall response of Complete Response (CR) or Partial Response (PR) according to RECIST. 1.1.
| Arm | Type | Description |
|---|---|---|
| Cohort 1 | EXPERIMENTAL | UTD2 40 mg/m2/d, po, qd, d1-5, q3w combined with CAPOX/FOLFOX with or without a PD-1 inhibitor ( tislelizumab, or pembrolizumab, or nivolumab ) |
| Cohort 2 | EXPERIMENTAL | UTD2 50 mg/m2/d, po, qd, d1-5, q3w combined with CAPOX/FOLFOX with or without a PD-1 inhibitor ( tislelizumab, or pembrolizumab, or nivolumab ) |
| Cohort 3 | EXPERIMENTAL | UTD2 60 mg/m2/d, po, qd, d1-5, q3w combined with CAPOX/FOLFOX with or without a PD-1 inhibitor ( tislelizumab, or pembrolizumab, or nivolumab ) |
| Arm A | EXPERIMENTAL | UTD2 po, on d1-5, q3w (dose decided after the phase II) in combination with CAPOX |
| Arm B | ACTIVE_COMPARATOR | CAPOX |
| Cohort 2 initial group | EXPERIMENTAL | - |
| Cohort 2 escalation group | EXPERIMENTAL | - |
| Cohort 2 de-escalation group | EXPERIMENTAL | - |
| Gastric cancer group | EXPERIMENTAL | - |
| Ovarian and cholangiocarcinoma groups | EXPERIMENTAL | - |
| Other oncology indications (including esophageal cancer, liver cancer, colorectal cancer, cervical c | EXPERIMENTAL | - |
| Squamous cell carcinoma of head and neck: Utidelone Injection | EXPERIMENTAL | Cohort 1 Squamous cell carcinoma of head and neck. Participants will be treated with utidelone monotherapy |
| Esophageal cancer: Utidelone injection | EXPERIMENTAL | Cohort 2 Esophageal cancer. Participants will be treated with utidelone monotherapy. |
| Stomach cancer: Utidelone injection | EXPERIMENTAL | Cohort 3 Stomach cancer. Participants will be treated with utidelone monotherapy. |
| Pancreatic cancer: Utidelone Injection | EXPERIMENTAL | Cohort4 Pancreatic cancer. Participants will be treated with Utidelone monotherapy. |
| Ovarian cancer: Utidelone Injection | EXPERIMENTAL | Cohort5 Ovarian cancer. Participants will be treated with Utidelone monotherapy. |
| Cholangiocarcinoma: Utidelone | EXPERIMENTAL | Cohort 6 Cholangiocarcinoma. Participants will be treated with Utidelone monotherapy |
| Other solid tumors: Utidelone Injection | EXPERIMENTAL | Cohort 7 Other solid tumors. Participants will be treated with Utidelone monotherapy |
| utidelone | EXPERIMENTAL | Utidelone Injection: 30 mg/m2/day, IV on day 1-day 5 of each 21 day cycle, administered to enrolled patients with advanced NSCLC |
| Name | Type | Description |
|---|---|---|
| Utidelone Capsule | DRUG | UTD2 40 mg/m2/d, po, qd, day 1-5, q3w |
| Fluoropyrimidine- and Platinum-containing Therapy | DRUG | CAPOX: Capecitabine 1700 mg/m2/d, po, bid, d1-14，q3w, Oxaliplatin 130 mg/m2, iv, d1, q3w. After completing 6 times (18 weeks) of oxaliplatin treatment, the investigator may decide whether to continue oxaliplatin treatment for up to 8 times (24 weeks) based on the participant's benefits and safety. FOLFOX: Oxaliplatin 85 mg/m2, iv, d1, q2w. Folinic Acid 400 mg/m2, iv, d1, q2w, 5-FU 400 mg/m2 IV bolus d1 then 5-FU 2400 mg/m2 IV infusion over 46 to 48 hours, q2w. After completing 9 times (18 weeks) of treatment with oxaliplatin combined with folinic acid and 5-FU, the investigator may decide whether to continue FOLFOX treatment for up to 12 times (24 weeks) based on the participant's benefits and safety. |
| Oxaliplatin | DRUG | 130 mg/m2/d, iv, day1, q3w, oxaliplatin will be given up to 6 cycles |
| PD-1 inhibitor | DRUG | Whether to combine a PD-1 inhibitor will depend on the locally approved indications for the PD-1 inhibitor. If the participant's condition meets the locally approved indications for PD-1 inhibitors, the investigator may determine, in accordance with clinical guidelines, that the participant is eligible to receive treatment with UTD2 combined with fluoropyrimidine- and platinum-containing therapy, with or without a PD-1 inhibitor. If a PD-1 inhibitor is administered in combination, tislelizumab (200 mg), or pembrolizumab (200 mg), or nivolumab (360 mg), iv, day1, q3w. Alternatively, the investigator may select the dosage and administration cycle of other locally approved PD-1 inhibitors in accordance with the locally approved package inserts. The PD-1 inhibitor will be given up to 2 years. |
| Capecitabine | DRUG | Capecitabine 1700 mg/m2/d po, bid, d1-14，q3w |
| Utidelone capsule 75mg/m2/d QD | DRUG | 75mg/m2/d, QD, D1-D5 for 5 consecutive days, every 21 days as a treatment cycle. |
| Utidelone capsule 40mg/m2/d BID | DRUG | 40mg/m2/d, BID, D1-D5 for 5 consecutive days, every 21 days as a treatment cycle. |
| Utidelone capsule 50mg/m2/d BID | DRUG | 50mg/m2/d, BID, D1-D5 for 5 consecutive days, every 21 days as a treatment cycle. |
| Utidelone capsule 35mg/m2/d BID | DRUG | 35mg/m2/d, BID, D1-D5 for 5 consecutive days, every 21 days as a treatment cycle. |
| Utidelone Capsule 60mg/m2/d | DRUG | 60mg/m2/d, D1-D5 for 5 consecutive days, every 21 days as a treatment cycle. |
| Utidelone capsule 75mg/m2 | DRUG | 75mg/m2/d, D1-D5 for 5 consecutive days, every 21 days as a treatment cycle. |
| utidelone injection | DRUG | Utidelone monotherapy 35 mg/m2/day IV transfusing over 90 min. on day 1-day 5 of each 21 day cycle |
Inclusion Criteria: * Participants must meet the following criteria to be eligible for the study: 1. Sign the informed consent form (ICF) to participate with accordance with GCP, ICH and local regulations and are willing to adhere to the study protocol. 2. Male and female aged ≥ 18 years as of...