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| ID | Type | Description | Link |
|---|---|---|---|
| KEYNOTE-F58 (MK-3475-F58) | Other Identifier | Merck Sharp & Dohme, LLC |
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| Name | Class |
|---|---|
| Merck Sharp & Dohme LLC | INDUSTRY |
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This is a first-in-human, Phase 1/2, open-label, dose escalation and dose expansion and combination study designed to evaluate the safety, tolerability, pharmacokinetics, pharmacodynamics, and preliminary efficacy of Spevatamig (PT886). Patients with the following tumor types will be eligible for screening: unresectable or metastatic gastric adenocarcinoma, gastroesophageal junction (GEJ) adenocarcinoma, biliary tract carcinoma (BTC) and pancreatic ductal adenocarcinoma (PDAC).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Dose Escalation | Experimental | An accelerated titration design will be employed for early dose levels, followed by the standard 3+3 design at higher dose levels. |
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| Dose Expansion | Experimental | Two dose levels will be explored; the recommended dose for expansion (RDE) from Part A, and another dose level. |
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| Combination Expansion with Chemotherapy | Experimental | Part C, substudy C1: 2L m/a GC/GEJ-C patients will receive Spevatamig (PT886) in combination with Paclitaxel. Part C, substudy C2: 1L m/a PDAC patients will receive Spevatamig (PT886) in combination with Gemcitabine plus nab-Paclitaxel (Abraxane). Part C, substudy C3: 1L m/a PDAC patients will receive Spevatamig (PT886) in combination with Gemcitabine plus FOLFIRINOX/mFFX. Part C, substudy C4: 2L BTC patients will receive PT886 in combination with SOC chemotherapy mFOLFOX6. |
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| Combination Expansion with KEYTRUDA® (pembrolizumab) | Experimental | Part D, substudy D3: 2L or 3L m/a GC/GEJ-C patients will receive Spevatamig (PT886) in combination with KEYTRUDA® (pembrolizumab). Part D, substudy D4: 1L HER2 negative m/a GC/GEJ-C patients will receive Spevatamig (PT886) in combination with SOC chemotherapy and KEYTRUDA® (pembrolizumab). |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Spevatamig (PT886) | Drug | Spevatamig (PT886) monotherapy, a novel bispecific antibody that targets Claudin 18.2 and CD47. |
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| Measure | Description | Time Frame |
|---|---|---|
| To evaluate the safety and tolerability of Spevatamig (PT886) as monotherapy and in each individual combination substudy. | Through study completion, an average of 2 years | |
| To evaluate anti-tumor activity of PT886 as assessed by ORR, in Spevatamig (PT886) monotherapy and in each combination substudy. | Through study completion. | |
| To determine the recommended dose for expansion of Spevatamig (PT886) monotherapy. | Through study completion. |
| Measure | Description | Time Frame |
|---|---|---|
| To evaluate the pharmacokinetics of Spevatamig (PT886). | Through study completion, an average of 2 years | |
| To evaluate the immunogenicity (ADA) of Spevatamig (PT886). | Through study completion, an average of 2 years |
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Key Inclusion Criteria
18 years or older and able to sign informed consent and comply with the protocol.
Measurable disease as defined by RECIST V1.1 criteria for solid tumors.
3. Part A and Part B: Histologically or cytologically confirmed unresectable advanced or metastatic solid gastric, gastroesophageal junction (GEJ), biliary tract or pancreatic carcinomas previously treated for advanced (metastatic or unresectable) disease or for which treatment is not available or not tolerated.
Part C, substudy C1: 2L m/a GC/GEJ-C patients will receive Spevatamig (PT886) in combination with Paclitaxel. Patients who are HER2 positive are eligible.
Part C, substudy C2: 1L m/a PDAC patients will receive Spevatamig (PT886) in combination with Gemcitabine plus nab-Paclitaxel (Abraxane).
Part C, substudy C3: 1L m/a PDAC patients will receive Spevatamig (PT886) in combination with Gemcitabine plus FOLFIRINOX/mFFX.
Part C, substudy C4: Patients with m/a BTC who have progressed on 1L SOC chemotherapy (GemCis) ± ICI and are eligible for 2L SOC FOLFOX treatment.
Part D, substudy D3: 2L or 3L m/a GC/GEJ-C patients will receive Spevatamig (PT886) in combination with KEYTRUDA® (pembrolizumab).
Part D, substudy D4: 1L HER2 negative m/a GC/GEJ-C patients will receive Spevatamig (PT886) in combination with SOC chemotherapy and KEYTRUDA® (pembrolizumab).
Able to provide a formalin fixed, paraffin embedded (FFPE) tumor tissue sample (preferably fresh biopsy or if not possible, archival tissue) to be assessed for CLDN18.2 expression and other biomarkers.
ECOG performance status of 0 or 1.
Adequate organ function confirmed at screening and within 72 hours of initiating treatment.
Key Exclusion Criteria
Patients are excluded from the study if any of the following criteria apply:
Additional inclusion and exclusion criteria will apply.
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Phanes Therapeutics | Contact | 858-766-0852 | clinical-trials@phanestx.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| City of Hope (City of Hope National Medical Center, City of Hope Medical Center) | Recruiting | Duarte | California | 91010 | United States |
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| Paclitaxel | Drug | Chemotherapy as a combination partner to Spevatamig (PT886) in Part C: substudy C1 |
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| Gemcitabine | Drug | Chemotherapy as a combination partner to Abraxane and Spevatamig (PT886) in Part C: substudy C2 |
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| Abraxane | Drug | Chemotherapy as a combination partner to Gemcitabine and Spevatamig (PT886) in Part C: substudy C2 |
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| KEYTRUDA® (pembrolizumab) | Drug | Immune checkpoint inhibitor as a combination partner to Spevatamig (PT886) in Part D. |
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| FOLFOX | Drug | Chemotherapy as a combination partner to Spevatamig (PT886) and KEYTRUDA® (pembrolizumab, Part D only) |
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| CAPOX | Drug | Chemotherapy as a combination partner to KEYTRUDA® (pembrolizumab) and Spevatamig (PT886) |
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| FOLFIRINOX | Drug | Chemotherapy as a combination partner to Spevatamig (PT886) in Part C: substudy C3 |
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| To evaluate anti-tumor activity as assessed by additional measures other than ORR, in Spevatamig (PT886) monotherapy and in each combination substudy. | Through study completion, an average of 2 years |
| USC Norris Comprehensive Cancer Center | Recruiting | Los Angeles | California | 90033 | United States |
| Sarah Cannon Research Institute (SCRI) | Recruiting | Denver | Colorado | 80218 | United States |
| University of Iowa | Recruiting | Iowa City | Iowa | 52242 | United States |
| Norton Cancer Institute | Recruiting | Louisville | Kentucky | 40202 | United States |
| Dana-Farber Cancer Institute (DFCI) | Active, not recruiting | Boston | Massachusetts | 02215 | United States |
| Duke Cancer Center | Recruiting | Durham | North Carolina | 27710 | United States |
| University of Pittsburgh Medical Center (UPMC) | Recruiting | Pittsburgh | Pennsylvania | 15232 | United States |
| MD Anderson Cancer Center, GI Medical Oncology Dept | Recruiting | Houston | Texas | 77030 | United States |
| NEXT Oncology | Recruiting | Fairfax | Virginia | 22031 | United States |
| University of Wisconsin Carbone Cancer Center - University Hospital | Recruiting | Madison | Wisconsin | 53792 | United States |
| ID | Term |
|---|---|
| D001661 | Biliary Tract Neoplasms |
| ID | Term |
|---|---|
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D001660 | Biliary Tract Diseases |
| D004066 | Digestive System Diseases |
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| ID | Term |
|---|---|
| D017239 | Paclitaxel |
| D000093542 | Gemcitabine |
| D000068196 | Albumin-Bound Paclitaxel |
| C582435 | pembrolizumab |
| C410216 | Folfox protocol |
| C000627770 | folfirinox |
| ID | Term |
|---|---|
| D043823 | Taxoids |
| D043822 | Cyclodecanes |
| D003516 | Cycloparaffins |
| D006840 | Hydrocarbons, Alicyclic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D004224 | Diterpenes |
| D013729 | Terpenes |
| D006571 | Heterocyclic Compounds |
| D003841 | Deoxycytidine |
| D003562 | Cytidine |
| D011741 | Pyrimidine Nucleosides |
| D011743 | Pyrimidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D000418 | Albumins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
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