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Pancreatic AdenocarcinomaPhase 1PANSOTONCT06892054

Sotorasib Combined With First-line Chemotherapy for Advanced Pancreatic Adenocarcinoma

A Phase 1 study testing Sotorasib, 960 mg, oral daily dose for 4 weeks (28 days) in people with Pancreatic Adenocarcinoma, run by Spanish Cooperative Group for the Treatment of Digestive Tumours (TTD) at 26 sites in 2 countries.

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

The main objective of this trial is to evaluate the safety and tolerability of sotorasib combined with first-line chemotherapy for advanced pancreatic adenocarcinoma harboring KRAS p.G12C mutation. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Pancreatic Adenocarcinoma
What is being tested?
Sotorasib, 960 mg, oral daily dose for 4 weeks (28 days)
Could I receive a placebo?
No, everyone receives an active treatment
How many people
15 participants
Where
26 sitesin 2 countries
Study dates
8 Aug 2025to 8 Aug 2030
Phase
Phase 1
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

  • 1) Willing and able to provide informed consent. 2) Men or women aged ≥ 18 years old. 3) Using effective contraceptive measures or sexual abstinence during the treatment, up to 7 days after the last dose of sotorasib, for at least 6 months after the last dose of gem/nab-P and for 15 months after the last dose of mFOLFIRINOX for woman of childbearing age and 12 months after stopping mFOLFIRINOX for men:
  • Female of childbearing potential using a highly effective method of contraception (i.e., a method with less than 1% failure rate [e.g., sterilization, hormone implants, hormone injections, some intrauterine devices, or vasectomized partner])
  • Male agreeing to use condoms or having a partner who is using a highly efficient method of contraception as described above 4) Pathologically confirmed treatment-naïve of locally advanced or metastatic pancreatic adenocarcinoma harboring KRAS p.G12C mutation assessed by means of a IVDR compliant test) 5) Measurable disease per RECIST 1.1 criteria. 6) Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1. 7) Life expectancy > 3 months, in the opinion of the investigator. 8) Adequate hematologic, renal and hepatic organ function, defined as the following within 10 days prior study inclusion:
  • Absolute neutrophil count (ANC) ≥ 1.5 x 109/L (without granulocyte colony-stimulating factor support within 2 weeks of laboratory test used to determine eligibility)
  • Hemoglobin ≥ 9.0 g/dL (without transfusion within 2 weeks of laboratory test used to determine eligibility)
  • Platelet count ≥ 100 x 109/L (without transfusion within 2 weeks of laboratory test used to determine eligibility)
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  • Aspartate aminotransferase (AST) and ALT ≤ 2.5 times the upper limit of normal (ULN) or ≤5 times if liver metastasis
  • Serum bilirubin ≤ 1.5 x ULN
  • International normalized ratio (INR) ≤ 1.5 x ULN. Prothrombin time (PT) ≤ 1.5 x ULN may be used instead of INR for sites whose laboratory do not report INR
  • Creatinine clearance ≥ 30 mL/min (estimated by Cockcroft-Gault equation) 9) Ability to take oral medications and willing to record daily adherence to investigational product.

Who cannot join

  • Patients with resectable or borderline resectable pancreatic cancer.
  • Known history or positive viral test for human immunodeficiency virus (HIV).
  • Peripheral sensory neuropathy. 4 )Proven complete dihydropyrimidine dehydrogenase (DPD) deficiency for patients that will be treated with mFOLFIRINOX.
  • 5) Poor nutritional status (albumin <3 g/L or weight loss >10% during the last 4 weeks).
  • 6) Patients with known active hepatitis (i.e., Hepatitis B or C)
  • Active hepatitis B virus (HBV) is defined by a known positive HBV surface antigen (HBsAg) result. Patients with a past or resolved HBV infection (defined as the presence of hepatitis B core antibody and absence of HBsAg) are eligible
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  • Patients positive for hepatitis C virus (HCV) antibody are eligible only if polymerase chain reaction is negative for HCV RNA 7) Female: currently pregnant or breast-feeding or who plan to breastfeed while on study though 7 additional days after the last dose of sotorasib and for at least 6 months afterwards after the last dose of gem/nab-P or 15 months after the last dose of mFOLFIRINOX.
  • 8) Myocardial infarction within 6 months of study Day 1, symptomatic congestive heart failure (New York Heart Association > class II), unstable angina, or cardiac arrhythmia requiring medication 9) Prior anti-tumor treatment for metastatic or locally advanced pancreatic adenocarcinoma. Prior chemotherapy or radiotherapy in the adjuvant or neoadjuvant setting is acceptable if received > 6 months prior to study enrolment
  • If initiation of treatment is deemed urgent by the investigator, patients can receive 1st month of Standard of Care (SoC) gem/nab-P (1 cycle) or FOLFIRINOX (2 cycles) during screening. This first month of gem/nab-P or FOLFIRINOX is not a requirement of the study and is not part of this clinical study 10) Active infection requiring antibiotics within 1 weeks of study enrollment. 11) Other malignancy unless curatively treated with no evidence of disease for ≥2 years except: adequately treated non-melanoma skin cancer, curatively treated in situ cancer of the cervix, and/or ductal carcinoma in situ.
  • 12) Significant gastrointestinal disorder that results in significant malabsorption, requirement for IV alimentation, or inability to take oral medication.
  • 13) History of interstitial pneumonitis or pulmonary fibrosis or evidence of interstitial pneumonitis or pulmonary fibrosis.
  • 14) Presence of any condition that, in the opinion of the investigator, renders the patient at high risk from treatment complications or might affect the interpretation of the results of the study.
  • 15) Significant uncontrolled concomitant disease that could affect compliance with protocol procedures or interpretation of results or that pose a risk to patient safety, in the opinion of the investigator.
  • 16) Uncontrolled pleural effusion, pericardial effusion, or ascites requiring recurrent drainage procedures at a frequency greater than monthly. Patients with PleurX catheters or intraperitoneal drainage catheters in place may be considered for the study with Medical Monitor approval.
  • 17) Major surgery within 4 weeks of study Day 1 18) Prior/concomitant therapy:
  • Previous treatment with a KRASG12C inhibitor
  • Use of warfarin. Other anticoagulation may be allowed
  • Use of known cytochrome P450 (CYP) 3A4 sensitive substrates and P-glycoprotein (P-gp) substrates (with a narrow therapeutic window), within 14 days or 5 half-lives of the drug or its major active metabolite, whichever is longer, prior to study Day 1 (see examples of sensitive substrates and P-glycoprotein substrates in Appendix A) except for those investigational treatments administered as part of the study scheme that will be subject to specific PK analysis.
  • Use of strong inducers of CYP3A4 (including herbal supplements such as St John's wort) within 14 days or 5 half-lives (whichever is longer) prior to study Day 1 (see examples of strong inducers of CYP3A4 in Appendix A)
  • Live attenuated vaccines (against yellow fever, chickenpox, shingles, measles, mumps, rubella, tuberculosis, rotavirus and influenza), within 30 days prior of the first dose of study treatment.
  • Brivudine-based treatments within 4 weeks before treatment with 5-fluorouracil. 19) Patient has known sensitivity to any of the products or components to be administered during the study.
  • 20) History or evidence of any other clinically significant disorder, condition or disease (with the exception of those outlined above) that, in the opinion of the investigator would pose a risk to patient safety or interfere with the study evaluation, procedures, or completion.

Trial locations and contacts

26 sites in 2 countries. Contact the study team or a site near you to ask about taking part.

Grupo de Tratamiento de los Tumores Digestivos contact

+034 913 788 275

secretariattd@ttdgroup.org

26 sites in 2 countries

Spain16 sites, 16 recruiting

  • Hospital Clínic

    Barcelona, Barcelona

    Florian Castet, MD

    Florian Castet, MD

    Recruiting

  • Hospital Universitari Vall D'Hebron

    Barcelona, Barcelona

    Jaume Capdevila, MD

    Recruiting

  • Institut Català D'Oncologia L'Hospitalet (Ico)

    Barcelona, Barcelona

    Berta Laquente Saez, MD

    Recruiting

  • Hospital Reina Sofía

    Córdoba, Córdoba

    Maria Teresa Cano Osuna, MD

    Recruiting

  • Hospital Universitario Donostia-Donostia Unibertsitate Ospitalea

    Donostia / San Sebastian, Guipúzcoa

    Beatriz Sánchez Casi, MD

    Recruiting

  • Hospital Clínico San Carlos

    Madrid, Madrid

    Beatriz García Paredes, MD

    Recruiting

  • Hospital General Universitario Gregorio Marañón

    Madrid, Madrid

    Andrés Muñoz, MD

    Recruiting

  • Hospital Universitario 12 de Octubre

    Madrid, Madrid

    Rocío García Carbonero, MD

    Recruiting

  • Complejo Hospitalario Regional de Málaga

    Málaga, Málaga

    Inmaculada Ales, MD

    Recruiting

  • Complexo Hospitalario Universitario de Ourense

    Ourense, OURENSE

    Ana Fernández Montes, MD

    Recruiting

  • Hospital Universitario Central de Asturias

    Oviedo, Principality of Asturias

    Paula Jiménez Fonseca, MD

    Recruiting

  • Complejo Hospitalario de Navarra

    Pamplona, Navarre

    Ruth Vera, MD

    Recruiting

  • Hospital Universitario de Salamanca

    Salamanca, SALAMANCA

    Luis Miguel Navarro Martín, MD

    Recruiting

  • Hospital Universitario Marqués de Valdecilla

    Santander, Cantabria

    Eva Martínez de Castro, MD

    Recruiting

  • Hospital General Universitario de Valencia

    Valencia, Valencia

    Miriam Lobo de Mena, MD

    Recruiting

  • Hospital Universitario Miguel Servet

    Zaragoza, Aragon

    Roberto Pazo, MD

    Recruiting

Other trials in Spain

France10 sites, 10 recruiting

  • Sainte Catherine - Institut Avignon Provence

    Avignon, France

    Clemence Toullec, MD

    Not yet recruiting

  • Chu Besançon - Hôpital Jean Minjoz

    Besançon, France

    Angélique Vienot, MD

    Not yet recruiting

  • Chu Brest - Hôpital Morvan

    Brest, France

    Jean Philippe Metges, MD

    Not yet recruiting

  • Chu de Lille - Claude Huriez

    Lille, France

    Pauline Parent, MD

    Not yet recruiting

  • Hôpital Léon Berard

    Lyon, France

    Philippe Cassier, MD

    Not yet recruiting

  • Chu Bordeaux - Hôpital Haut Lévêque

    Pessac, France

    Jean Frederic Blanc, MD

    Not yet recruiting

  • Chu Poitiers

    Poitiers, France

    David Tougeron, MD

    Not yet recruiting

  • Chu Reims - Hôpital Robert Debré

    Reims, France

    Olivier Bouche, MD

    Not yet recruiting

  • Chu Toulouse

    Toulouse, France

    Nadim Fares, MD

    Not yet recruiting

  • Hôpital Paul-Brousse

    Villejuif, France

    Pascal Hammel, MD

    Not yet recruiting

Other trials in France

About this study

Official title: Sotorasib Combined With First-line Chemotherapy for Advanced Pancreatic Adenocarcinoma With KRAS p.G12C Mutation

The main objective of this trial is to evaluate the safety and tolerability of sotorasib combined with first-line chemotherapy for advanced pancreatic adenocarcinoma harboring KRAS p.G12C mutation.

Read the detailed description

This is a phase 1b, multicenter and open-label study of first-line chemotherapy (gemcitabine combined with nab-paclitaxel [gem/nab-P] or modified FOLFIRINOX [mFOLFIRINOX]) in combination with sotorasib for patients with locally advanced or metastatic pancreatic cancer harboring KRAS p.G12C mutation.The study will be conducted at approximately 25 sites distributed in two countries (Spain and France). The study will consist of a screening period, a treatment period, a safety follow-up (SFU) and long-term follow-up (LTFU) period. A minimum of 6 and a maximum of 15 patients will be enrolled to receive first-line chemotherapy (gem/nab-P or mFOLFIRINOX at investigator choice) in combination with sotorasib 960 mg daily (QD). An independent data monitoring committee (DMC) is planned for this study to review safety, PK, and, if applicable, efficacy data as per DMC charter. A minimum the two DMC is planned: one meeting after the first 3 evaluable patients have completed 1 month of treatment with sotorasib combined with mFOLFIRINOX, and the other meeting after the first 3 evaluable patients have completed 1 month of treatment with sotorasib combined with gem/nab-P. Patients may discontinue treatment because of disease progression, intolerance of treatment leading to treatment discontinuation, initiation of another anticancer therapy, or withdrawal of consent.

Being tested
Sotorasib, 960 mg, oral daily dose for 4 weeks (28 days)
Keywords
Pancreatic, sotorasib, TTD-24-01, KRASG12C

What participants receive

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

  • Sotorasib, 960 mg, oral daily dose for 4 weeks (28 days)Drug

    Also called Lumykras

    A minimum of 6 and a maximum of 15 patients will be enrolled to receive first-line chemotherapy (gem/nab-P or mFOLFIRINOX at investigator choice) in combination with sotorasib 960 mg daily (QD). The treatment with gem/nab-P and mFOLFIRINOX should be managed as per clinical practice.

Study groups in NCT06892054
Study groupRoleWhat they receive
First-line chemotherapy (gem/nab-P or FOLFIRINOX) combined with sotorasibExperimentalA minimum of 6 and a maximum of 15 patients will be enrolled to receive first-line chemotherapy (gem/nab-P or mFOLFIRINOX at investigator choice) in combination with sotorasib 960 mg daily (QD).mFOLFIRINOX is recommended for patients with ECOG PS of 0 to 1, favourable comorbidity profile, patient preference and a support system for aggressive medical therapy, and access to chemotherapy port and infusion pump management services. Gem/nab-P is recommended for patients with ECOG PS of 0 to 1, a relatively favourable comorbidity profile, and patient preference and a support system for relatively aggressive medical therapy. Gem/nab-P is therefore the preferred first line treatment for patients expected to be intolerant to mFOLFIRINOX.
Receives: Drug: Sotorasib, 960 mg, oral daily dose for 4 weeks (28 days)

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 sotorasib combined with first-line chemotherapy for locally advanced or metastatic pancreatic adenocarcinoma harboring KRAS p.G12C mutation.

    Incidence of treatment-emergent adverse events (TEAEs) and related TEAEs (TRAEs) according to CTCAE V5.0.

    Measured: 60 months

Secondary outcomes (6)

  1. To evaluate the progression-free survival assessed by CT or MRI using RECIST 1.1 criteria of first-line chemotherapy combined with sotorasib for advanced pancreatic adenocarcinoma harboring KRAS p.G12C mutation

    Progression-Free Survival (PFS) is defined as time from the first day of the study treatment (Day 1) until disease progression or death from any cause, whichever occurs first, for all patients, according to the investigator criteria.

    Measured: 60 months

  2. To evaluate the overall survival of first-line chemotherapy combined with sotorasib for advanced pancreatic adenocarcinoma harboring KRAS p.G12C mutation.

    The overall survival (OS) is defined as time from Day 1 until death from any cause.

    Measured: 60 months

  3. Overall response (OR)

    The overall response (OR) is defined as the best overall response complete response (CR) or partial response (PR), assessed per RECIST 1.1.

    Measured: 60 months

  4. Disease control (DC)

    The disease control (DC) is defined as the best overall response of CR or PR or of stable disease.

    Measured: 60 months

  5. Duration of response (DOR)

    The duration of response (DOR) is defined as the time from onset of response to progression or death due to any reason, whichever occurs earlier.

    Measured: 60 months

  6. Duration of stable disease

    The duration of stable disease is defined as the time from first disease control to disease progression per RECIST 1.1 criteria or death (due to any cause). For patients with disease control who have not progressed or died at last observation, duration of disease control will be censored at their last evaluable disease assessment date.

    Measured: 60 months

Timeline

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

  1. First posted24 Mar 2025
  2. Study start8 Aug 2025
  3. Primary completion8 Aug 2030 (estimated)
  4. Study completion8 Aug 2030 (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
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
15 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06892054
Sponsor's protocol ID
TTD-24-01
Other IDs
2024-516233-12-00
Acronym
PANSOTO
Status last verified
Apr 2026
First submitted
5 Feb 2025
Last updated
30 Apr 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing Sotorasib, 960 mg, oral daily dose for 4 weeks (28 days) in people with Pancreatic Adenocarcinoma, run by Spanish Cooperative Group for the Treatment of Digestive Tumours (TTD) at 26 sites in 2 countries.

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 10 inclusion and 22 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 30 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 26 sites in Spain, France. 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 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.

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 Grupo de Tratamiento de los Tumores Digestivos (+034 913 788 275, secretariattd@ttdgroup.org), 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 sotorasib combined with first-line chemotherapy for locally advanced or metastatic pancreatic adenocarcinoma harboring KRAS p.G12C mutation. (time frame: 60 months). 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 NCT06892054.

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 30 Apr 2026.

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