Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
PM8002 · 12 trials · 11 indications
Overall survival is defined as the time from randomization to death due to any cause. Participants without documented death at the time of the analysis are censored at the date of the last follow-up.
Progression-free survival is defined as the time from randomization to the first documented progressive disease (PD) per Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST 1.1) based on assessments by Blinded Independent Review Committee (BIRC) or death due to any cause, whichever occurs first. Per RECIST 1.1, PD is defined as ≥20% increase in the sum of diameters of target lesions. In addition to the relative increase of 20%, the sum must also have demonstrated an absolute increase of ≥5 mm. The appearance of one or more new lesions is also considered PD.
Objective response rate is the proportion of subjects with complete response (CR) or partial response (PR), based on RECIST v1.1.
AEs are graded according to Common Terminology Criteria for Adverse Events (CTCAE) V5.0 in the combination treatment regimen.
Objective response rate (ORR) is the proportion of subjects with complete response (CR) or partial response (PR), based on RECIST v1.1
The incidence and severity of TRAEs graded according to NCI-CTCAE v5.0
ORR is the proportion of subjects with complete response (CR) or partial response (PR), based on RECIST v1.1.
To determine the dosing regimen of PM8002 in combination with PM1009
DLTs will be assessed during the dose-escalation phase and are defined as toxicities that meet pre-defined severity criteria and assessed as having a suspected relationship to study drug, and unrelated to disease, disease progression, intercurrent illness, or concomitant medications that occurs within the first cycle (3weeks) of treatment.
| Arm | Type | Description |
|---|---|---|
| PM8002+Paclitaxel | EXPERIMENTAL | Subjects will be administered with PM8002 in combination with Paclitaxel via intravenously (IV) infusion. |
| Chemotherapy | ACTIVE_COMPARATOR | Subjects will be administered with Investigator's Choice(Topotecan or Paclitaxel) via intravenously (IV) infusion Q3W. |
| PM8002 Plus Nab-Paclitaxel | EXPERIMENTAL | Patients will receive both PM8002 and Nab-Paclitaxel. |
| Placebo Plus Nab-Paclitaxel | PLACEBO_COMPARATOR | Patients will receive both Placebo and Nab-Paclitaxel. |
| Chemotherapy regimen 1 group - PM8002 Dose 1 + chemotherapy regimen 1 | EXPERIMENTAL | Subjects will be administered with PM8002 (Dose 1) plus chemotherapy regimen 1 via intravenously (IV) Q2W until progression. |
| Chemotherapy regimen 1 group - PM8002 Dose 2 + chemotherapy regimen 1 | EXPERIMENTAL | Subjects will be administered with PM8002 (Dose 2) plus chemotherapy regimen 1 via intravenously (IV) Q2W until progression. |
| Chemotherapy regimen 2 group - PM8002 Dose 1 + chemotherapy regimen 2 | EXPERIMENTAL | Subjects will be administered with PM8002 (Dose 1) plus chemotherapy regimen 2 via intravenously (IV) and oral administration (PO) Q3W until progression. |
| Chemotherapy regimen 2 group - PM8002 Dose 2 + chemotherapy regimen 2 | EXPERIMENTAL | Subjects will be administered with PM8002 (Dose 2) plus chemotherapy regimen 2 via intravenously (IV) and oral administration (PO) Q3W until progression. |
| Chemotherapy regimen 3 group - PM8002 Dose 1 + chemotherapy regimen 3 | EXPERIMENTAL | Subjects will be administered with PM8002 (Dose 1) plus chemotherapy regimen 3 via intravenously (IV) Q2W until progression. |
| Chemotherapy regimen 3 group - PM8002 Dose 2 + chemotherapy regimen 3 | EXPERIMENTAL | Subjects will be administered with PM8002 (Dose 2) plus chemotherapy regimen 3 via intravenously (IV) Q2W until progression. |
| PM8002+Chemotherapy | EXPERIMENTAL | Subjects will be administered with PM8002 plus pemetrexed and carboplatin via intravenously (IV) Q3W for 4 cycles, followed by PM8002 and pemetrexed until progression or for a maximum of 2 years. |
| PM8002+Etoposide＋platinum | EXPERIMENTAL | Subjects will be administered with PM8002 plus Etoposide and platinum via intravenously (IV) Q3W for 4 cycles, followed by PM8002 until progression or for a maximum of 2 years. |
| PM8002+FOLFIRI | EXPERIMENTAL | Subjects will be administered with PM8002 plus FOLFIRI via intravenously (IV) Q2W until disease progression or intolerable toxicity for a maximum of 2 years. |
| PM8002+pemetrexed+platinum | OTHER | Subjects will be administered with PM8002 plus pemetrexed+platinum via intravenously (IV) Q3W for 4-6 cycles,followed by PM8002 until disease progression intolerable toxicity for a maximum of 2 years. |
| PM8002+FOLFOX-4 | EXPERIMENTAL | PM8002 20mg/kg Q2W day 1: oxaliplatin \[85 mg/m2, 2-h infusion\] plus leucovorin \[200 mg/m2, 2-h infusion\], followed by 5-fluorouracil \[400 mg/m2, intravenous bolus; 600 mg/m2, 22-h infusion\]; day 2: leucovorin \[200 mg/m2, 2-h infusion\], followed by 5-fluorouracil \[400 mg/m2, intravenous bolus; 600 mg/m2, 22-h infusion\] |
| Cohort 1- combination treatment | EXPERIMENTAL | Combination regimen：PM8002 combined with PM1009. The drugs are administered on the first day every 3 weeks (Q3W), until disease progression or intolerable toxicity or patient withdrawal or study discontinuation(Whichever occurs first). |
| Cohort 2- combination treatment | EXPERIMENTAL | Combination regimen：PM8002 combined with PM1009(low dose). The drugs are administered on the first day every 3 weeks (Q3W), until disease progression or intolerable toxicity or patient withdrawal or study discontinuation(Whichever occurs first). |
| Cohort 3- monotherapy | EXPERIMENTAL | PM8002 administered on the first day every 3 weeks (Q3W), until disease progression or intolerable toxicity or patient withdrawal or study discontinuation(Whichever occurs first). |
| Cohort 4 | ACTIVE_COMPARATOR | Combination regimen：atezolizumab combined with bevacizumab. The drugs are administered on the first day every 3 weeks (Q3W), until disease progression or intolerable toxicity or patient withdrawal or study discontinuation(Whichever occurs first). |
| PM8002+nab-paclitaxel | OTHER | PM8002 at 20 mg/kg (Q2W) and nab-paclitaxel at 100 mg/m2 on the 1st, 8th, and 15th days of each cycle until unacceptable toxicity or disease progression were observed. Each cycle contains 28 days. |
| PM8002 | EXPERIMENTAL | PM8002 IV every 2 weeks(q2w) or every 3 weeks(q3w) |
| Name | Type | Description |
|---|---|---|
| PM8002 | DRUG | Following a predefined dose and date. |
| Paclitaxel | DRUG | 175mg/m2 via IV infusion on Day 1 Q3W |
| Topotecan | DRUG | 1.25mg/m2/day via IV infusion on Days 1-5 Q3W |
| Nab-Paclitaxel | DRUG | Nab-Paclitaxel 100mg/m2 via IV infusion on Days 1, 8, and 15 of each 28-day cycle |
| Placebo | DRUG | Placebo 20 mg/kg via IV infusion on Days 1 and 15 of each 28-day cycle |
| Chemotherapy Regimen 1 | DRUG | IV infusion |
| Chemotherapy Regimen 2 | DRUG | Oral administration and IV infusion |
| Chemotherapy Regimen 3 | DRUG | IV infusion |
| Carboplatin | DRUG | IV infusion |
| Pemetrexed | DRUG | IV infusion |
| Platinum | DRUG | IV infusion |
| Etoposide | DRUG | IV infusion |
| FOLFIRI | DRUG | IV infusion |
| Cisplatin | DRUG | IV infusion |
| FOLFOX regimen | DRUG | day 1: oxaliplatin \[85 mg/m2, 2-h infusion\] plus leucovorin \[200 mg/m2, 2-h infusion\], followed by 5-fluorouracil \[400 mg/m2, intravenous bolus; 600 mg/m2, 22-h infusion\]; day 2: leucovorin \[200 mg/m2, 2-h infusion\], followed by 5-fluorouracil \[400 mg/m2, intravenous bolus; 600 mg/m2, 22-h infusion\] |
| PM1009 | DRUG | PM8002 via IV infusion, Q3W |
| atezolizumab | DRUG | atezolizumab,1200mg, via IV infusion, Q3W |
| bevacizumab | DRUG | bevacizumab,15mg/kg, via IV infusion, Q3W |
Inclusion Criteria: 1. Voluntary participation in this clinical study; full understanding of the study and voluntary signing the informed consent form; willing to follow and abling to complete all trial procedures; 2. Age ≥18 years but ≤75 years; 3. Histologically or cytologically confirmed SCLC; 4...