PM8002 Clinical Trials (2026): 13 Studies for SCLC & HCC
Hipa.ai Research · Source: ClinicalTrials.gov / AACT
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13 PM8002 clinical trials are catalogued on Hipa.ai from the AACT mirror of ClinicalTrials.gov, spanning 11 indications (including SCLC & HCC) and 1,836 total planned enrollment. 2 Phase 3 PM8002 trials and 8 Phase 2 are listed. 5 PM8002 clinical trials are actively recruiting. Most recent activity: NCT06837948 (Dec 2031).
PM8002 clinical trials at a glance: phase × recruitment status
| Phase | recruiting | active not recruiting | completed | not yet recruiting | Total |
|---|---|---|---|---|---|
| P1/P2 | 1 | 1 | 1 | 3 | |
| P2 | 4 | 2 | 2 | 8 | |
| P3 | 1 | 1 | 2 |
Recruiting PM8002 clinical trials (5)
Studies currently enrolling participants. Click any NCT ID to view the trial detail page (eligibility, sites, contacts).
| NCT ID | Title | Phase | Indication | Enrollment | Started |
|---|---|---|---|---|---|
| NCT06837948 | Neoadjuvant Chemotherapy Combined With Bispecific Antibody Versus Monoclonal Antibody in Locally Advanced NSCLC | P2 | Locally Advanced Non-Small Cell Lung Cancer | 160 | Feb 2025 |
| NCT07133750 | BNT327PM8002 (BNT327) in Combination With Chemotherapy in Patients With Metastatic Colorectal Cancer | P2 | CRC (Colorectal Cancer) | 40 | Aug 2025 |
| NCT06419621 | PM8002 or Placebo Plus Nab-Paclitaxel as First-line Treatment in Inoperable Locally Advanced/Metastatic TNBC | P3 | Triple Negative Breast Cancer(TNBC) | 360 | Jun 2024 |
| NCT06584071 | A Study to Evaluate of PM8002 Combined With PM1009 in Patients With First-line HCC | P1/P2 | HCC | 140 | Dec 2024 |
| NCT05918445 | PM8002 in the Treatment of Patients With Advanced Solid Tumors | P1/P2 | Malignant Neoplasm | 380 | Mar 2021 |
PM8002 clinical trials by indication
SCLC (3)
| NCT | Acronym | Phase | Status | Title |
|---|---|---|---|---|
| NCT06616532 | — | P3 | active not recruiting | PM8002 in Combination With Paclitaxel Compared With Chemotherapy as Second-line Treatment in Small Cell Lung Cancer |
| NCT05879068 | — | P2 | active not recruiting | A Study of PM8002 in Combination With Chemotherapy in Patients With SCLC |
| NCT05844150 | — | P2 | active not recruiting | A Study of PM8002 (Anti-PD-L1/VEGF) in Combination With Chemotherapy in Patients With ES-SCLC |
CRC (Colorectal Cancer) (1)
| NCT | Acronym | Phase | Status | Title |
|---|---|---|---|---|
| NCT07133750 | BNT327 | P2 | not yet recruiting | PM8002 (BNT327) in Combination With Chemotherapy in Patients With Metastatic Colorectal Cancer |
Locally Advanced Non-Small Cell Lung Cancer (1)
| NCT | Acronym | Phase | Status | Title |
|---|---|---|---|---|
| NCT06837948 | — | P2 | not yet recruiting | Neoadjuvant Chemotherapy Combined With Bispecific Antibody Versus Monoclonal Antibody in Locally Advanced NSCLC |
HCC (1)
| NCT | Acronym | Phase | Status | Title |
|---|---|---|---|---|
| NCT06584071 | — | P1/P2 | not yet recruiting | A Study to Evaluate of PM8002 Combined With PM1009 in Patients With First-line HCC |
Triple Negative Breast Cancer(TNBC) (1)
| NCT | Acronym | Phase | Status | Title |
|---|---|---|---|---|
| NCT06419621 | — | P3 | recruiting | PM8002 or Placebo Plus Nab-Paclitaxel as First-line Treatment in Inoperable Locally Advanced/Metastatic TNBC |
NSCLC (1)
| NCT | Acronym | Phase | Status | Title |
|---|---|---|---|---|
| NCT05756972 | — | P2 | active not recruiting | A Study of PM8002 (Anti-PD-L1/VEGF) in Combination With Chemotherapy in Patients With NSCLC |
Neuroendocrine Neoplasm (1)
| NCT | Acronym | Phase | Status | Title |
|---|---|---|---|---|
| NCT05879055 | — | P2 | active not recruiting | A Study of PM8002 in Combination With Chemotherapy in Patients With NEN |
MPM (1)
| NCT | Acronym | Phase | Status | Title |
|---|---|---|---|---|
| NCT05918107 | — | P2 | completed | A Study of PM8002 Injection in Combination With Standard Chemotherapy as First Line Therapy in MPM |
TNBC (1)
| NCT | Acronym | Phase | Status | Title |
|---|---|---|---|---|
| NCT05918133 | — | P1/P2 | active not recruiting | A Study of PM8002 Plus Nab-paclitaxel as First Line Therapy for TNBC |
Hepatocellular Carcinoma (1)
| NCT | Acronym | Phase | Status | Title |
|---|---|---|---|---|
| NCT05864105 | — | P2 | completed | PM8002 in Combination With Chemotherapy as First Line Therapy in Hepatocellular Carcinoma |
Malignant Neoplasm (1)
| NCT | Acronym | Phase | Status | Title |
|---|---|---|---|---|
| NCT05918445 | — | P1/P2 | recruiting | PM8002 in the Treatment of Patients With Advanced Solid Tumors |
PM8002 pivotal trial highlights (Phase 2/3/4)
Phase-2/3/4 studies with named acronyms — the registration-grade trials most cited in label discussions and Wikipedia.
| Acronym | NCT | Phase | Status | Indication | Enrollment | PubMed |
|---|---|---|---|---|---|---|
| BNT327 | NCT07133750 | P2 | not yet recruiting | CRC (Colorectal Cancer) | 40 | — |
All PM8002 trials (13)
Sorted by most recent activity (completion → start → posted date). Each row links to the trial detail page on Hipa.ai.
| NCT ID | Acronym | Title | Phase | Status | Enrollment | Sponsor | Started |
|---|---|---|---|---|---|---|---|
| NCT06837948 | Neoadjuvant Chemotherapy Combined With Bispecific Antibody Versus Monoclonal Antibody in Locally Advanced NSCLC | P2 | not yet recruiting | 160 | Shanghai Pulmonary Hospital, Shanghai, China | Feb 2025 | |
| NCT07133750 | BNT327 | PM8002 (BNT327) in Combination With Chemotherapy in Patients With Metastatic Colorectal Cancer | P2 | not yet recruiting | 40 | Biotheus Inc. | Aug 2025 |
| NCT06616532 | PM8002 in Combination With Paclitaxel Compared With Chemotherapy as Second-line Treatment in Small Cell Lung Cancer | P3 | active not recruiting | 404 | Biotheus Inc. | Nov 2024 | |
| NCT06419621 | PM8002 or Placebo Plus Nab-Paclitaxel as First-line Treatment in Inoperable Locally Advanced/Metastatic TNBC | P3 | recruiting | 360 | Biotheus Inc. | Jun 2024 | |
| NCT05879055 | A Study of PM8002 in Combination With Chemotherapy in Patients With NEN | P2 | active not recruiting | 31 | Biotheus Inc. | May 2023 | |
| NCT06584071 | A Study to Evaluate of PM8002 Combined With PM1009 in Patients With First-line HCC | P1/P2 | not yet recruiting | 140 | Biotheus Inc. | Dec 2024 | |
| NCT05918133 | A Study of PM8002 Plus Nab-paclitaxel as First Line Therapy for TNBC | P1/P2 | active not recruiting | 42 | Biotheus Inc. | Jul 2022 | |
| NCT05879068 | A Study of PM8002 in Combination With Chemotherapy in Patients With SCLC | P2 | active not recruiting | 99 | Biotheus Inc. | May 2022 | |
| NCT05918107 | A Study of PM8002 Injection in Combination With Standard Chemotherapy as First Line Therapy in MPM | P2 | completed | 31 | Biotheus Inc. | Aug 2022 | |
| NCT05756972 | A Study of PM8002 (Anti-PD-L1/VEGF) in Combination With Chemotherapy in Patients With NSCLC | P2 | active not recruiting | 64 | Biotheus Inc. | Jun 2023 | |
| NCT05844150 | A Study of PM8002 (Anti-PD-L1/VEGF) in Combination With Chemotherapy in Patients With ES-SCLC | P2 | active not recruiting | 50 | Biotheus Inc. | Jun 2023 | |
| NCT05918445 | PM8002 in the Treatment of Patients With Advanced Solid Tumors | P1/P2 | recruiting | 380 | Biotheus Inc. | Mar 2021 | |
| NCT05864105 | PM8002 in Combination With Chemotherapy as First Line Therapy in Hepatocellular Carcinoma | P2 | completed | 35 | Biotheus Inc. | Apr 2022 |
PM8002 clinical trials: frequently asked questions
- How many PM8002 clinical trials are there?
- 13 PM8002 clinical trials are catalogued on Hipa.ai, sourced from the AACT mirror of ClinicalTrials.gov. 2 are actively recruiting participants. 2 are marked completed.
- Are PM8002 clinical trials recruiting in 2026?
- Yes — 2 PM8002 trials are actively recruiting in 2026. See the recruiting trials and the per-state site list further down this page.
- What conditions is PM8002 being studied for?
- PM8002 is being studied for SCLC, HCC, Hepatocellular Carcinoma, Liver Cancer, Locally Advanced Non-Small Cell Lung Cancer and 7 more. The trials are grouped by indication on this page.
- What phase is PM8002 in?
- PM8002 clinical trials span 2 Phase 3, 8 Phase 2. The phase × status matrix at the top of this page breaks down counts by phase and recruitment status.
- Who sponsors PM8002 clinical trials?
- The lead sponsor across the most PM8002 trials is Biotheus Inc., with 1 additional lead sponsor listed in the data. Each trial row links to the full study detail page including sponsor information.
Sources and methodology
Trial inventory derived from the AACT mirror of ClinicalTrials.gov. Trials are filtered to those naming PM8002as an intervention. Phase, status, enrollment, sponsor, and dates are taken from the source `studies` table; primary indication is the first listed condition. Acronyms are extracted from each trial's brief title where present. PubMed links are populated for trials whose published primary outcomes have been indexed in our evidence cache.
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