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Metastatic Microsatellite Stable Colorectal CarcinomaPhase 1/2NCT07281716

Combination Immunotherapy for the Treatment of Chemotherapy-refractory Metastatic MSS CRC

A Phase 1/2 study testing Nadunolimab and Toripalimab in people with Metastatic Microsatellite Stable Colorectal Carcinoma, run by Dan Feng at 1 site 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

Phase 1b/2 open-label study evaluates the safety, tolerability, and efficacy of combination immunotherapy with nadunolimab (anti-IL-1RAP) and toripalimab (anti-PD-1) in patients with chemotherapy-refractory metastatic microsatellite stable (MSS) colorectal cancer. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
Nadunolimab and Toripalimab
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
24 participants
Where
1 siteUnited States
Study dates
1 Dec 2025to 15 Dec 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

  • Patients must have a pathologically confirmed diagnosis of non-MSI-H/pMMR CRC.
  • Patients must have progressed (clinically or radiographically) on or after standard chemotherapy, including fluoropyrimidines, oxaliplatin, and irinotecan, or are intolerant to standard chemotherapy. Patients may have received, if eligible, anti-VEGF or anti-EGFR antibodies in combination with chemotherapy.
  • Patients must have at least 1 measurable target lesion at baseline ≥ 10mm in the longest diameter.
  • Patient must be willing and able to provide blood samples (6 heparinized, and two streck tubes, roughly 70 - 80 mL) at the time points indicated in the Study Calendar.
  • Patients must have at least 1 lesion suitable for core needle biopsies.
  • Patients must be willing and able to have core needle biopsies, if clinically feasible (Goal 3-6 biopsies, final number to be determined by the interventionalist performing the procedure as safe), of tumor prior to initiation of study drug. Should patients undergo pre-treatment or on-treatment biopsy procedure and inadequate number of biopsies are obtained, they may proceed with initiation/continuation of treatment at the discretion of the investigator and treating physician.
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  • Age ≥ 18 years.
  • ECOG Performance Status 0-1 (Karnofsky ≥60%, see https://ecog-acrin.org/resources/ecog-performance-status/). o Patients with performance status >1 carrying long-term disability (such as cerebral palsy) where the disability is not acute nor progressive, and unlikely to significantly affect their response to therapy may be enrolled at the investigator's discretion
  • Women of child-bearing potential (WOCBP) and men must agree to use adequate contraception prior to study entry, for the duration of study participation, and for 4 months following completion of therapy. Should a study participant become pregnant or suspect pregnancy while participating in this study, the study participant should inform the treating physician immediately. A female of child-bearing potential is any woman (regardless of sexual orientation, having undergone a tubal ligation, or remaining celibate by choice) who meets the following criteria: o Has not undergone a hysterectomy or bilateral oophorectomy; or o Has not been naturally postmenopausal for at least 12 consecutive months
  • Ability to understand and the willingness to sign a written informed consent. • Adequate organ and marrow function

Who cannot join

  • Patients who have had chemotherapy within 14 days from start of therapy.
  • Palliative radiotherapy is permitted at anytime, if deemed in the best interest of the patient.
  • Patients may not be receiving any other investigational agents.
  • Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection requiring antibiotics (exception is a brief (≤10days) course of antibiotics to be completed before initiation of treatment), symptomatic congestive heart failure, unstable angina pectoris, or psychiatric illness/social situations that would limit compliance with study requirements.
  • Patients who have undergone major surgery within 4 weeks prior to the first dose of treatment.
  • Patients who are pregnant or nursing due to the potential for congenital abnormalities and the potential of this regimen to harm nursing infants.
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  • Patients who discontinued prior immune checkpoint inhibitors due to immune-related adverse events are not eligible for enrollment.
  • Has a diagnosis of immunodeficiency or is receiving systemic steroid therapy or any other form of immunosuppressive therapy within 7 days prior to the first dose of trial treatment. Patients on chronic steroids (more than 4 weeks at stable dose) equivalent to ≤ 10mg prednisone will not be excluded.
  • Has active autoimmune disease that has required systemic treatment in the past 1 year (i.e. with use of disease modifying agents, corticosteroids or immunosuppressive drugs). Replacement therapy (e.g. thyroxine, insulin, or physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency, etc.) is acceptable.
  • Has a history or current evidence of any condition, therapy, or laboratory abnormality that might confound the results of the trial, interfere with the patient's participation for the full duration of the trial, or is not in the best interest of the patient to participate, in the opinion of the treating Investigator.
  • HIV positive with detectable viral load, or anyone not on stable anti-viral (HAART) regimen, or with <200 CD4+ T cells/microliter in the peripheral blood. HIV testing is mandatory for patients with no known history of HIV. For such patients HIV testing will be considered SOC.
  • Has known active Hepatitis B (e.g., HBV detected by PCR or active Hepatitis C (e.g., HCV RNA [qualitative] is detected). Patients with hepatitis B (HepBsAg+) who have controlled infection (serum hepatitis B virus DNA PCR that is below the limit of detection AND receiving anti-viral therapy for hepatitis B) are permitted. Patients with controlled infections must undergo periodic monitoring of HBV DNA. Patients must remain on anti-viral therapy for at least 6 months beyond the last dose of investigational study drug.
  • History of allogeneic hematopoietic cell transplantation or solid organ transplantation.
  • Receipt of a live vaccine within 28 days of planned start of study medication.
  • Receipt of etanercept or other TNF-α inhibitors within 28 days of planned start of the study medication.
  • Documented allergic or hypersensitivity response to any protein therapeutics (e.g., recombinant proteins, vaccines, intravenous immune globulins, monoclonal antibodies, receptor traps).
  • Principal investigator believes that for one or multiple reasons the patient will be unable to comply with all study visits, or if they believe the trial is not clinically in the best interest of the patient.
  • History of irAE in response to prior immunotherapy that has not improved to a Grade 0 or 1; this does not include chronic conditions such as endocrinopathies which can be treated with hormone replacement therapy.
  • History of interstitial lung disease (e.g., idiopathic pulmonary fibrosis, organizing pneumonia) or active, noninfectious pneumonitis attributed to prior use of cancer immunotherapy that required immune-suppressive doses of glucocorticoids to assist with management. A history of radiation pneumonitis in the radiation field is permitted.

Trial locations and contacts

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

Jordan Cuevas contact

(212) 824-7945

Jordan.Cuevas@mssm.edu

Rashmi Unawane contact

(212) 824-2385

rashmi.unawane@mssm.edu

United States1 site, 1 recruiting

  • Icahn School of Medicine at Mount Sinai

    New York, New York, 10029

    Jordan Cuevas, (212) 824-7945, Jordan.Cuevas@mssm.edu

    Rashmi Unawane, 212-824-2385, Rashmi.Unawane@mssm.edu

    Recruiting

Other trials in United States

About this study

Official title: A Phase 1b/2 Study of Combination Immunotherapy for the Treatment of Chemotherapy-refractory Metastatic Microsatellite Stable (MSS) Colorectal Cancer (CRC)

Phase 1b/2 open-label study evaluates the safety, tolerability, and efficacy of combination immunotherapy with nadunolimab (anti-IL-1RAP) and toripalimab (anti-PD-1) in patients with chemotherapy-refractory metastatic microsatellite stable (MSS) colorectal cancer. Phase 1b will assess dose-limiting toxicity (DLT), while Phase 2 will evaluate objective response rate (ORR), including progression-free survival (PFS), overall survival (OS), disease control rate (DCR), and duration of response (DOR). Exploratory analyses will investigate immunomodulatory effects through tumor and peripheral blood studies, and treatment will continue every 3 weeks for up to 1 year or until disease progression.

Read the detailed description

This is a Phase 1b/2, open-label study evaluating the safety, tolerability, and efficacy of nadunolimab (anti-IL-1RAP) in combination with toripalimab (anti-PD-1) in adults with chemotherapy-refractory metastatic microsatellite stable (MSS) colorectal cancer. The Phase 1b portion serves as a safety run-in with up to 6 subjects to assess the safety of a single dose of the combination therapy. Following this, Phase 2 will enroll up to 21 subjects, with the first 6 from Phase 1b included in the Phase 2 analysis to assess the primary efficacy endpoint. Eligible participants must have biopsy-confirmed MSS colorectal cancer (non-MSI-high or pMMR), whose disease has progressed during or following 5-FU, oxaliplatin and/or irinotecan-based chemotherapy with or without a biological agent. Subjects must have have measurable disease and tumor accessible for core needle biopsy. Participants will receive nadunolimab 5 mg/kg and toripalimab 240 mg intravenously every three weeks, continuing for up to one year or until disease progression. Primary objectives: For Phase 1/b, to determine the safety and tolerability of combination immunotherapy in subjects with chemotherapy-refractory metastatic non-MSI-high/pMMR CRC. For Phase 2, to determine the efficacy of combination immunotherapy in subjects with chemotherapy-refractory metastatic non-MSI-high/pMMR CRC as measured by the objective response rate (ORR) achieved. Subjects will undergo core needle biopsies, blood collection, and repeat imaging throughout the study. This study is conducted at Mount Sinai Hospital under IRB and PRMC oversight. The results will provide important information on the safety and potential efficacy of combining nadunolimab and toripalimab in a population with limited treatment options.

Being tested
Nadunolimab, Toripalimab
Keywords
Colorectal Cancer(CRC), Chemotherapy-refractory colorectal cancer, Microsatellite stable colorectal cancer (MSS CRC), Metastatic colorectal cancer, Chemotherapy-resistant CRC
Medical subject headings
Colorectal Neoplasms

What participants receive

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

  • NadunolimabDrug

    5 mg/kg intravenously (IV) every 3 weeks (Q3W)

  • ToripalimabDrug

    240 mg IV every 3 weeks (Q3W)

Study groups in NCT07281716
Study groupRoleWhat they receive
Nadunolimab and ToripalimabExperimentalParticipants will receive the investigational combination of nadunolimab and toripalimab. Treatment will continue for up to 1 year or until disease progression, whichever occurs first.
Receives: Drug: Nadunolimab; Drug: Toripalimab

What is being measured

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

  1. Dose-Limiting Toxicities (DLTs)

    For the Phase 1b portion, Dose-Limiting Toxicities (DLTs) will be assessed based on the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version 5.0. Adverse events are graded on a scale from 1 (mild) to 5 (death related to AE). Permanent discontinuation of study treatment will occur for any severe (Grade 3) drug-related adverse event that recurs or for any life-threatening (Grade 4) event.

    Measured: The first cycle (day1 - day21) constitutes the DLT window.

  2. Objective Response Rate (ORR)

    For the phase 2 portion, ORR will be assessed based on the definition, as the combined percent of the subjects experiencing a partial response (PR) or a complete response (CR) at anytime within the first year from the initiation of therapy, or until the documented progression of disease or start of a new anti-cancer therapy. Radiographic response will be determined by the RECIST v1.1

    Measured: Treatment initiation through 12 months, or until documented disease progression or initiation of new anti-cancer therapy, whichever occurs first

Secondary outcomes (4)

  1. Progression-free Survival (PFS)

    Progression-free survival (PFS) is defined as the time in days from the first administration of nadunolimab until documented progression of disease on imaging or death.

    Measured: From first dose through disease progression, death, or up to 12 months, whichever occurs first.

  2. Overall survival (OS)

    Overall survival (OS) is defined as the time in days from the first administration of nadunolimab until documented death from any cause.

    Measured: From first administration of nadunolimab until documented death from any cause, or up to 12 months, whichever occurs first.

  3. Disease control rate (DCR)

    Disease control rate (DCR) is defined as the percent of the subjects experiencing a best objective response of PR, CR or stable disease (SD).

    Measured: From first administration of nadunolimab until best objective response, or up to 12 months, whichever occurs first.

  4. Duration of response (DOR)

    Duration of response (DOR) is defined as the time from which a subject achieves either a PR or a CR until subsequent progression of disease is documented radiographically or clinically.

    Measured: up to 12 months

Timeline

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

  1. First posted15 Dec 2025
  2. Study start1 Dec 2025
  3. Primary completion15 Dec 2028 (estimated)
  4. Study completion15 Dec 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
Not applicable
Intervention model
Sequential
Model description
3+3 run-in subjects, first 3 subjects will be enrolled and the first constitutes the DLT window. If there are 2 or more subjects experiencing a DLT, the trial will be halted and the treatment plan discussed with the Tisch Cancer Institute DSMC. If 0 or 1 subject experience a DLT, 3 more subjects will be enrolled. If 2+ subjects experience a DLT the trial will be halted and the treatment plan discussed with the DSMC. If at most 1 out of 6 subjects experiences a DLT, Phase 2 of the trial will open. The 6 subjects from the Phase 1b portion will be evaluable as part of the Phase 2 cohort of 21 subjects and will follow a two-stage minimax design, with 12 subjects in Stage 1 and 9 subjects in Stage 2. A safety stopping rule for futility will be applied and expect that 10% of participants could be expected to drop out either in the phase 1b or phase 2 and will be replaced. Therefore, the total number of subjects that could be enrolled in order to obtain 21 evaluable subjects will be 24
Masking
None (open label)
Enrolment
24 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07281716
Sponsor's protocol ID
STUDY-25-00756
Other IDs
PRMC-25-046 IIT
Status last verified
Dec 2025
First submitted
25 Nov 2025
Last updated
19 Feb 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No: The completed dataset is the sole property of the Sponsor-Investigator's institution and should not be exported to third parties, except for authorized representatives of appropriate Health/Regulatory Authorities, without permission from the Sponsor-investigator and their institution.

Publications

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    PubMed 26028255

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    PubMed 37133585

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    PubMed 33724754

  • Pages F, Mlecnik B, Marliot F, Bindea G, Ou FS, Bifulco C, Lugli A, Zlobec I, Rau TT, Berger MD, Nagtegaal ID, Vink-Borger E, Hartmann A, Geppert C, Kolwelter J, Merkel S, Grutzmann R, Van den Eynde M, Jouret-Mourin A, Kartheuser A, Leonard D, Remue C, Wang JY, Bavi P, Roehrl MHA, Ohashi PS, Nguyen LT, Han S, MacGregor HL, Hafezi-Bakhtiari S, Wouters BG, Masucci GV, Andersson EK, Zavadova E, Vocka M, Spacek J, Petruzelka L, Konopasek B, Dundr P, Skalova H, Nemejcova K, Botti G, Tatangelo F, Delrio P, Ciliberto G, Maio M, Laghi L, Grizzi F, Fredriksen T, Buttard B, Angelova M, Vasaturo A, Maby P, Church SE, Angell HK, Lafontaine L, Bruni D, El Sissy C, Haicheur N, Kirilovsky A, Berger A, Lagorce C, Meyers JP, Paustian C, Feng Z, Ballesteros-Merino C, Dijkstra J, van de Water C, van Lent-van Vliet S, Knijn N, Musina AM, Scripcariu DV, Popivanova B, Xu M, Fujita T, Hazama S, Suzuki N, Nagano H, Okuno K, Torigoe T, Sato N, Furuhata T, Takemasa I, Itoh K, Patel PS, Vora HH, Shah B, Patel JB, Rajvik KN, Pandya SJ, Shukla SN, Wang Y, Zhang G, Kawakami Y, Marincola FM, Ascierto PA, Sargent DJ, Fox BA, Galon J. International validation of the consensus Immunoscore for the classification of colon cancer: a prognostic and accuracy study. Lancet. 2018 May 26;391(10135):2128-2139. doi: 10.1016/S0140-6736(18)30789-X. Epub 2018 May 10.

    PubMed 29754777

  • Diakos CI, Charles KA, McMillan DC, Clarke SJ. Cancer-related inflammation and treatment effectiveness. Lancet Oncol. 2014 Oct;15(11):e493-503. doi: 10.1016/S1470-2045(14)70263-3.

    PubMed 25281468

  • Mantovani A, Allavena P, Sica A, Balkwill F. Cancer-related inflammation. Nature. 2008 Jul 24;454(7203):436-44. doi: 10.1038/nature07205.

    PubMed 18650914

  • Binnewies M, Roberts EW, Kersten K, Chan V, Fearon DF, Merad M, Coussens LM, Gabrilovich DI, Ostrand-Rosenberg S, Hedrick CC, Vonderheide RH, Pittet MJ, Jain RK, Zou W, Howcroft TK, Woodhouse EC, Weinberg RA, Krummel MF. Understanding the tumor immune microenvironment (TIME) for effective therapy. Nat Med. 2018 May;24(5):541-550. doi: 10.1038/s41591-018-0014-x. Epub 2018 Apr 23.

    PubMed 29686425

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    PubMed 28475888

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    PubMed 25464849

  • Salmon H, Idoyaga J, Rahman A, Leboeuf M, Remark R, Jordan S, Casanova-Acebes M, Khudoynazarova M, Agudo J, Tung N, Chakarov S, Rivera C, Hogstad B, Bosenberg M, Hashimoto D, Gnjatic S, Bhardwaj N, Palucka AK, Brown BD, Brody J, Ginhoux F, Merad M. Expansion and Activation of CD103(+) Dendritic Cell Progenitors at the Tumor Site Enhances Tumor Responses to Therapeutic PD-L1 and BRAF Inhibition. Immunity. 2016 Apr 19;44(4):924-38. doi: 10.1016/j.immuni.2016.03.012.

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  • Garris CS, Arlauckas SP, Kohler RH, Trefny MP, Garren S, Piot C, Engblom C, Pfirschke C, Siwicki M, Gungabeesoon J, Freeman GJ, Warren SE, Ong S, Browning E, Twitty CG, Pierce RH, Le MH, Algazi AP, Daud AI, Pai SI, Zippelius A, Weissleder R, Pittet MJ. Successful Anti-PD-1 Cancer Immunotherapy Requires T Cell-Dendritic Cell Crosstalk Involving the Cytokines IFN-gamma and IL-12. Immunity. 2018 Dec 18;49(6):1148-1161.e7. doi: 10.1016/j.immuni.2018.09.024. Epub 2018 Dec 11.

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  • LaMarche NM, Hegde S, Park MD, Maier BB, Troncoso L, Le Berichel J, Hamon P, Belabed M, Mattiuz R, Hennequin C, Chin T, Reid AM, Reyes-Torres I, Nemeth E, Zhang R, Olson OC, Doroshow DB, Rohs NC, Gomez JE, Veluswamy R, Hall N, Venturini N, Ginhoux F, Liu Z, Buckup M, Figueiredo I, Roudko V, Miyake K, Karasuyama H, Gonzalez-Kozlova E, Gnjatic S, Passegue E, Kim-Schulze S, Brown BD, Hirsch FR, Kim BS, Marron TU, Merad M. An IL-4 signalling axis in bone marrow drives pro-tumorigenic myelopoiesis. Nature. 2024 Jan;625(7993):166-174. doi: 10.1038/s41586-023-06797-9. Epub 2023 Dec 6.

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  • Rizvi NA, Hellmann MD, Snyder A, Kvistborg P, Makarov V, Havel JJ, Lee W, Yuan J, Wong P, Ho TS, Miller ML, Rekhtman N, Moreira AL, Ibrahim F, Bruggeman C, Gasmi B, Zappasodi R, Maeda Y, Sander C, Garon EB, Merghoub T, Wolchok JD, Schumacher TN, Chan TA. Cancer immunology. Mutational landscape determines sensitivity to PD-1 blockade in non-small cell lung cancer. Science. 2015 Apr 3;348(6230):124-8. doi: 10.1126/science.aaa1348. Epub 2015 Mar 12.

    PubMed 25765070

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing Nadunolimab and Toripalimab in people with Metastatic Microsatellite Stable Colorectal Carcinoma, run by Dan Feng at 1 site 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 10 inclusion and 19 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 19 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site 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 Jordan Cuevas ((212) 824-7945, Jordan.Cuevas@mssm.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Dose-Limiting Toxicities (DLTs) (time frame: The first cycle (day1 - day21) constitutes the DLT window.). The study lists 2 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 NCT07281716, which also lists 20 linked publications.

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 19 Feb 2026.

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