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Spevatamig (PT886) as Monotherapy or in Combination With Chemo and/or ICI, for the Treatment of Patients With Advanced Gastric, Gastroesophageal Junction, Pancreatic Ductal or Biliary Tract Carcinomas (the TWINPEAK Study)

ConditionsGastric or Gastroesophageal Junction AdenocarcinomaPancreatic Ductal AdenocarcinomaBiliary Tract Cancer (BTC)
Trial statusRecruiting
Trial phasePhase 1, Phase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorPhanes Therapeutics

About this trial

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).

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

ECOG performance status of 0 or 1.

Disqualifiers

Women who are pregnant or lactating.

Women of child-bearing potential (WOCBP) who do not use adequate birth control.

Has an active autoimmune disease that has required systemic treatment in the past 2 years.

Condition requiring systemic treatment with either corticosteroids or other immunosuppressive medications within 14 days prior to study treatment.

Trial design

Design model

Sequential

Treatments tested in this trial

  • Spevatamig (PT886)

    Drug

    Spevatamig (PT886) monotherapy, a novel bispecific antibody that targets Claudin 18.2 and CD47.

  • Paclitaxel

    Drug

    Chemotherapy as a combination partner to Spevatamig (PT886) in Part C: Cohort C1

  • Gemcitabine

    Drug

    Chemotherapy as a combination partner to Abraxane and Spevatamig (PT886) in Part C: Cohort C2

  • Abraxane

    Drug

    Chemotherapy as a combination partner to Gemcitabine and Spevatamig (PT886) in Part C: Cohort C2

  • KEYTRUDA® (pembrolizumab)

    Drug

    Immune checkpoint inhibitor as a combination partner to Spevatamig (PT886) in Part D: Cohort D2, D3 and D4.

  • Oxaliplatin

    Drug

    Chemotherapy as a combination partner to KEYTRUDA® (pembrolizumab) and Spevatamig (PT886) in Part D: Cohort D4

  • Leucovorin

    Drug

    Chemotherapy as a combination partner to KEYTRUDA® (pembrolizumab) and Spevatamig (PT886) in Part D: Cohort D4

  • Fluorouracil

    Drug

    Chemotherapy as a combination partner to KEYTRUDA® (pembrolizumab) and Spevatamig (PT886) in Part D: Cohort D4

  • Capecitabine

    Drug

    Chemotherapy as a combination partner to KEYTRUDA® (pembrolizumab) and Spevatamig (PT886) in Part D: Cohort D4

  • FOLFIRINOX

    Drug

    Chemotherapy as a combination partner to Spevatamig (PT886) in Part C: Cohort C3

Treatment groups

258 Participants
are divided into 4 treatment groups
Group A: Dose EscalationExperimental treatment 1 intervention
Group B: Dose ExpansionExperimental treatment 1 intervention
Group C: Combination Expansion with ChemotherapyExperimental treatment 9 interventions
Group D: Combination Expansion with KEYTRUDA® (pembrolizumab)Experimental treatment 6 interventions

Trial outcomes

Primary outcomes

1

To determine the dose-limiting toxicity (DLT) of Spevatamig (PT886).

Time frame
Through study completion.
2

To determine the maximum tolerated dose (MTD) of Spevatamig (PT886).

Time frame
Through study completion.
3

To evaluate the safety and tolerability of Spevatamig (PT886).

Time frame
Through study completion, an average of 2 years

Secondary outcomes

1

To evaluate the pharmacokinetics of Spevatamig (PT886).

Time frame
Through study completion, an average of 2 years
2

To evaluate the immunogenicity (ADA) of Spevatamig (PT886).

Time frame
Through study completion, an average of 2 years
3

Preliminary Efficacy of Spevatamig (PT886).

Time frame
Through study completion.

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Phanes Therapeutics

Lead sponsor

Merck Sharp & Dohme LLC

Collaborator

Source ClinicalTrials.gov
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