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Gastric or Gastroesophageal Junction AdenocarcinomaPhase 1/2NCT05482893

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

A Phase 1/2 study testing Spevatamig (PT886), Paclitaxel and Gemcitabine in people with Gastric or Gastroesophageal Junction Adenocarcinoma and Pancreatic Ductal Adenocarcinoma, run by Phanes Therapeutics at 11 sites in United States.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
Search all trials

Trial summary

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). Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
Spevatamig (PT886), Paclitaxel and Gemcitabine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
350 participants
Where
11 sitesUnited States
Study dates
15 Mar 2023to Apr 2028
Phase
Phase 1/2
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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: 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 B: Patients with PDAC and GC/GEJC must meet the same criteria as those in Part A depending on which indication and line of treatment are chosen for expansion. Patients considered 2L with BTC, without actionable genomic mutations. Patients considered 3L with CRC.
  • Part C, substudy C1: patients with 2L m/a GC/GEJ-C will receive Spevatamig (PT886) in combination with Paclitaxel. Patients who are HER2 positive are eligible.
  • Part C, substudy C2: patients with 1L m/a PDAC will receive Spevatamig (PT886) in combination with Gemcitabine plus nab-Paclitaxel (Abraxane).
Show all 16Show fewer
  • Part C, substudy C3: patients with 1L m/a PDAC will receive Spevatamig (PT886) in combination with Gemcitabine plus FOLFIRINOX/mFFX or NALIRIFOX.
  • Part C, substudy C4: Patients with m/a BTC without actionable genomic mutations who have progressed on 1L SOC chemotherapy (GemCis) ± ICI and are eligible for 2L SOC FOLFOX treatment.
  • Part C, substudy C5 and C7: Patients with CRC who are considered 3L, TAS-102 treatment naïve, eligible to receive 3L SOC TAS-102 treatment, and able to swallow oral tablets.
  • Part C, substudy C6 and C7: Patients with CRC who are considered 3L, and eligible to receive bevacizumab treatment, with no contraindication to bevacizumab
  • Part D, substudy D2: patients with m/a BTC with adenocarcinoma histology only, who are treatment naïve for their m/a disease and are eligible for treatment with SOC chemotherapy and ICI.
  • Part D, substudy D3: patients with 2L or 3L m/a GC/GEJ-C will receive Spevatamig (PT886) in combination with KEYTRUDA® (pembrolizumab).
  • Part D, substudy D4: patients with 1L HER2 negative m/a GC/GEJ-C 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.

Who cannot join

  • Patients are excluded from the study if any of the following criteria apply:
  • 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.
  • Prior CLDN18.2 or CD47 targeting therapies, or SIRPα (signal regulatory protein alpha) targeting agents.
  • Additional inclusion and exclusion criteria will apply.

Trial locations and contacts

11 sites in 1 country. Contact the study team or a site near you to ask about taking part.

Phanes Therapeutics contact

858-766-0852

clinical-trials@phanestx.com

11 sites in 1 country

United States11 sites, 10 recruiting

  • Dana-Farber Cancer Institute (DFCI)

    Boston, Massachusetts, 02215

    Active, not recruiting

  • Sarah Cannon Research Institute (SCRI)

    Denver, Colorado, 80218

    Recruiting

  • City of Hope (City of Hope National Medical Center, City of Hope Medical Center)

    Duarte, California, 91010

    Recruiting

  • Duke Cancer Center

    Durham, North Carolina, 27710

    Recruiting

  • NEXT Oncology

    Fairfax, Virginia, 22031

    Recruiting

  • MD Anderson Cancer Center, GI Medical Oncology Dept

    Houston, Texas, 77030

    Recruiting

  • University of Iowa

    Iowa City, Iowa, 52242

    Recruiting

  • USC Norris Comprehensive Cancer Center

    Los Angeles, California, 90033

    Recruiting

  • Norton Cancer Institute

    Louisville, Kentucky, 40202

    Recruiting

  • University of Wisconsin Carbone Cancer Center - University Hospital

    Madison, Wisconsin, 53792

    Recruiting

  • University of Pittsburgh Medical Center (UPMC)

    Pittsburgh, Pennsylvania, 15232

    Recruiting

Other trials in United States

About this study

Official title: A Phase 1/2, Open-Label, Dose Escalation and Expansion Study With PT886 Followed by a Multi-cohorT Study in Patients With Advanced Gastrointestinal Cancers, Including GastrIc, Gastroesophageal JuNction, Pancreatic Ductal or Biliary Tract AdEnocarcinomas of PT886, in Combination With ChemotherApy, Targeted Therapy, and/or an Immune ChecKpoint Inhibitor. The TWINPEAK Study

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), pancreatic ductal adenocarcinoma (PDAC) and colorectal carcinoma (CRC).

Being tested
Spevatamig (PT886), Paclitaxel, Gemcitabine, Abraxane, KEYTRUDA® (pembrolizumab)
Medical subject headings
Biliary Tract Neoplasms, Colorectal Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Spevatamig (PT886)Drug

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

  • PaclitaxelDrug

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

  • GemcitabineDrug

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

  • AbraxaneDrug

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

  • KEYTRUDA® (pembrolizumab)Drug

    Immune checkpoint inhibitor as a combination partner to Spevatamig (PT886) in Part D.

  • FOLFOXDrug

    Chemotherapy as a combination partner to Spevatamig (PT886) and KEYTRUDA® (pembrolizumab, Part D only)

  • CAPOXDrug

    Chemotherapy as a combination partner to KEYTRUDA® (pembrolizumab) and Spevatamig (PT886)

  • FOLFIRINOXDrug

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

  • TAS 102Drug

    Chemotherapy as a combination partner to Spevatamig (PT886) in Part C: substudies C5 and C7.

  • BevacizumabDrug

    Targeted therapy as a combination partner to Spevatamig (PT886) in Part C: substudies C6 and C7.

  • Gemcitabine Combined With CisplatinDrug

    Chemotherapy as a combination partner to Spevatamig (PT886) and KEYTRUDA® (pembrolizumab) in Part D: substudy D2

  • NALIRIFOXDrug

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

Study groups in NCT05482893
Study groupRoleWhat they receive
Dose EscalationExperimentalAn accelerated titration design will be employed for early dose levels, followed by the standard 3+3 design at higher dose levels.
Receives: Drug: Spevatamig (PT886)
Dose ExpansionExperimentalOne or more indications (GC/GEJC, BTC, CRC or PDAC) and/or lines of treatment may be selected for dose expansion at two dose levels (RDE1 and RDE2).
Receives: Drug: Spevatamig (PT886)
Combination Expansion with Chemotherapy or Targeted TherapyExperimentalPart C, substudy C1: patients with 2L m/a GC/GEJ-C will receive Spevatamig (PT886) in combination with Paclitaxel. Part C, substudy C2: patients with 1L m/a PDAC will receive Spevatamig (PT886) in combination with Gemcitabine plus nab-Paclitaxel (Abraxane). Part C, substudy C3: patients with 1L m/a PDAC will receive Spevatamig (PT886) in combination with Gemcitabine plus FOLFIRINOX/mFFX or NALIRIFOX. Part C, substudy C4: patients with 2L BTC will receive PT886 in combination with SOC chemotherapy mFOLFOX6. Part C, substudy C5: patients with 3L CRC patients will receive PT886 in combination with SOC chemotherapy TAS-102. Part C, substudy C6: patients with 3L CRC patients will receive PT886 in combination with bevacizumab. Part C, substudy C7: patients with 3L CRC patients will receive PT886 in combination with SOC chemotherapy TAS-102 and bevacizumab.
Receives: Drug: Spevatamig (PT886); Drug: Paclitaxel; Drug: Gemcitabine; Drug: Abraxane; Drug: FOLFOX; Drug: FOLFIRINOX; Drug: TAS 102; Drug: Bevacizumab; Drug: NALIRIFOX
Combination Expansion with KEYTRUDA® (pembrolizumab)ExperimentalPart D, substudy D2: patients with 1L BTC will receive Spevatamig (PT886) in combination with KEYTRUDA® (pembrolizumab) and standard of care chemotherapy GemCis. Part D, substudy D3: patients with 2L or 3L m/a GC/GEJ-C will receive Spevatamig (PT886) in combination with KEYTRUDA® (pembrolizumab). Part D, substudy D4: patients with 1L HER2 negative m/a GC/GEJ-C will receive Spevatamig (PT886) in combination with SOC chemotherapy and KEYTRUDA® (pembrolizumab).
Receives: Drug: Spevatamig (PT886); Drug: KEYTRUDA® (pembrolizumab); Drug: FOLFOX; Drug: CAPOX; Drug: Gemcitabine Combined With Cisplatin

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. To evaluate the safety and tolerability of Spevatamig (PT886) as monotherapy and in each individual combination substudy.

    Measured: Through study completion, an average of 2 years

  2. To evaluate anti-tumor activity of PT886 as assessed by ORR, in Spevatamig (PT886) monotherapy and in each combination substudy.

    Measured: Through study completion.

  3. To determine the recommended dose for expansion of Spevatamig (PT886) monotherapy.

    Measured: Through study completion.

Secondary outcomes (3)

  1. To evaluate the pharmacokinetics of Spevatamig (PT886).

    Measured: Through study completion, an average of 2 years

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

    Measured: Through study completion, an average of 2 years

  3. To evaluate anti-tumor activity as assessed by additional measures other than ORR, in Spevatamig (PT886) monotherapy and in each combination substudy.

    Measured: Through study completion, an average of 2 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted1 Aug 2022
  2. Study start15 Mar 2023
  3. Primary completionDec 2027 (estimated)
  4. Study completionApr 2028 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1/2
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Sequential
Masking
None (open label)
Enrolment
350 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05482893
Sponsor's protocol ID
PT886X1101
Other IDs
KEYNOTE-F58 (MK-3475-F58)
Status last verified
Sep 2026
First submitted
25 Jul 2022
Last updated
28 Sep 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing Spevatamig (PT886), Paclitaxel and Gemcitabine in people with Gastric or Gastroesophageal Junction Adenocarcinoma and Pancreatic Ductal Adenocarcinoma, run by Phanes Therapeutics at 11 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 16 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 28 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 11 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this combined phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Phanes Therapeutics (858-766-0852, clinical-trials@phanestx.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

To evaluate the safety and tolerability of Spevatamig (PT886) as monotherapy and in each individual combination substudy. (time frame: Through study completion, an average of 2 years). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05482893.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Sep 2026.

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