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Patients With Unresectable Colorectal Cancer Requiring First-Line or Second-Line TherapyPhase 2NCT07895355

Phase II Clinical Study of RC148 (ABBV-1480) in Combination With Telisotuzumab Adizutecan (With or Without Chemotherapy) for Unresectable Colorectal Cancer

A Phase 2 study testing RC148 plus Telisotuzumab adizutecan and Telisotuzumab adizutecan plus Bevacizumab in people with Patients With Unresectable Colorectal Cancer Requiring First-Line or Second-Line Therapy, run by RemeGen Co., Ltd. at 1 site in China.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts
Official record
Search all trials

Trial summary

RC148 (ABBV-1480) in Combination With Telisotuzumab Adizutecan (With or Without Chemotherapy) for Unresectable Colorectal Cancer Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
RC148 plus Telisotuzumab adizutecan and Telisotuzumab adizutecan plus Bevacizumab
Could I receive a placebo?
No, everyone receives an active treatment
How many people
412 participants
Where
1 siteChina
Study dates
Nov 2026to Jan 2030
Phase
Phase 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

  • Voluntarily participate in the study and sign the informed consent form
  • Be willing to and able to act on the trial and the follow-up procedures
  • At least 18 years old
  • Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
  • Life expectancy ≥ 12 weeks
  • Participants have histologically or cytologically confirmed unresectable adenocarcinoma of the colon or rectum
Show all 10Show fewer
  • At least one lesion with measurable disease based on RECIST v1.1 as determined by the local site investigator/radiology assessment
  • All participants must have an evaluable c-Met expression result per central IHC testing, a RAS status report, and a MSI/MMR report prior to the first dose of study treatment
  • Adequate bone marrow, hepatic, renal and coagulation functions
  • Female participants must be postmenopausal or surgically sterilized, or must have a negative blood pregnancy test within 7 days prior to the first dose for women of childbearing potential, and agree to take at least one medically accepted contraceptive measure during the treatment and within 12 months following the end of treatment, and must not donate eggs or breast-feeding. Male participants must agree to take at least one medically accepted contraceptive measure during the treatment period and within 12 months following the end of treatment, and must not donate sperm during this period

Who cannot join

  • Participants are dMMR/MSI-H or have known BRAF V600E mutation
  • Known active CNS metastases and/or carcinomatous meningitis.
  • The images during the screening indicating obvious necrosis or cavity in tumor that may increase the risk of hemorrhage as determined by investigators, tumor invasion of major blood vessels or vital organs, the risk of fistula, or tumor encasing major blood vessels, or imaging evidence indicating participating in the study may increase the risk of hemorrhage
  • History of interstitial lung disease or pneumonitis that required treatment with systemic steroids, or any evidence of active ILD/pneumonitis on screening chest CT scan
  • History of idiopathic pulmonary fibrosis, organizing pneumonia, treatment-induced pneumonitis, idiopathic pneumonitis, or radiation pneumonitis
  • History of clinically significant, intercurrent lung-specific illnesses including
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  • Uncontrollable cardiovascular diseases
  • Active inflammatory bowel disease (including but not limited to ulcerative colitis and Crohn's disease; Abdominal fistula, GI perforation, peptic ulcer, or intra-abdominal abscess within 6 months prior to the first dose; Imaging evidence of gastrointestinal obstruction or clinical symptoms and signs of gastrointestinal obstruction
  • Ongoing serious, non-healing wound, ulcer, or bone fracture
  • History of clinically significant arterial thrombotic or embolic events e.g., deep venous thrombosis, pulmonary embolism or cerebral vascular accident
  • Active gastrointestinal bleeding, hemoptysis , peptic ulcer, or bleeding events requiring intervention within 28 days prior to the first dose; or had severe esophageal and gastric varices, epistaxis , or clinically significant coagulopathy
  • Serious acute or chronic infections
  • Third space effusion with clinical symptoms or requiring intervention.
  • History of liver cirrhosis
  • Uncontrolled diabetes
  • Active or history of autoimmune diseases that may relapse.
  • History of other acquired or congenital immunodeficiency diseases or organ transplantation.
  • Known history of prior malignancy except if the participant has undergone potentially curative therapy with no evidence of that disease recurrence for 5 years since initiation of that therapy
  • Toxicity not recovered from prior anticancer therapy, defined as not recovered to NCI CTCAE v6.0 Grade 1 or baseline level, or at the level specified in the inclusion/exclusion criteria,s.
  • History of an allergic reaction or significant sensitivity to constituents of the study treatment and/or other products in the same class
  • Have any other diseases, metabolic abnormalities, abnormal physical examinations or laboratory tests, indicating reasonable possibility, as determined by investigators, that the participants have diseases or conditions disqualified him/her for the investigational drugs, the interpretation of the study results may be impacted, or the participants may be put at high risk
  • Prior systemic regimen containing Irinotecan or c-Met targeting antibody or c-Met targeting ADC, or any Top1i ADC
  • Received any prior tumor immunotherapy
  • Participants treated with any investigational treatment within 28 days or 5 half-lives of the treatment prior to the first dose of study treatment or is currently enrolled in another clinical study or was previously enrolled in this study
  • Received chest radiotherapy of > 30 Gy within 6 months prior to the first dose and/or received palliative local therapy within 2 weeks prior to the first dose
  • Received nonspecific immunomodulatory therapy or received herbal supplements or traditional Chinese medicines that are intending to treat cancer within 1 weeks prior to the first dose of study drugs
  • Participant has received any live vaccine within 4 weeks prior to the first dose of study treatment, or expected need of live vaccination during study participation including at least 4 weeks after the last dose of study treatment
  • Systemic treatment with corticosteroids or other immunosuppressive drugs within 2 weeks prior to the first dose of study drugs
  • Participants receiving anticoagulant drugs.
  • Major surgical procedure within 28 days, or anticipation of the need for major surgical procedure during the study, and minor surgical procedure within 7 days prior to study enrollment

Trial locations and contacts

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

Jiang Guo contact

010-65384976

jiang.guo@remegen.com

China1 site

  • Sun Yat-sen University Cancer Center

    Guangdong, Guangzhou

Other trials in China

About this study

Official title: A Phase 2, Randomized, Multicenter Study to Evaluate the Efficacy and Safety of RC148 (ABBV-1480) in Combination With Telisotuzumab Adizutecan With or Without Chemotherapy as a First-Line or Second-Line Therapy for Unresectable Colorectal Cancer

RC148 (ABBV-1480) in Combination With Telisotuzumab Adizutecan (With or Without Chemotherapy) for Unresectable Colorectal Cancer

Being tested
RC148 plus Telisotuzumab adizutecan, Telisotuzumab adizutecan plus Bevacizumab

What participants receive

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

  • RC148 plus Telisotuzumab adizutecanDrug

    Dose 1/ Dose 1

  • RC148 plus Telisotuzumab adizutecanDrug

    Dose 2/ Dose 1

  • RC148 plus Telisotuzumab adizutecanDrug

    Dose 3/ Dose 2

  • RC148 plus Telisotuzumab adizutecanDrug

    Dose 2/ Dose 2

  • Telisotuzumab adizutecan plus BevacizumabDrug

    Dose 1

  • Telisotuzumab adizutecan plus BevacizumabDrug

    Dose 2

Study groups in NCT07895355
Study groupRoleWhat they receive
Dose1 RC148 plus Dose1 Telisotuzumab adizutecanExperimentalNot described
Receives: Drug: RC148 plus Telisotuzumab adizutecan
Dose2 RC148 plus Dose1 Telisotuzumab adizutecanExperimentalNot described
Receives: Drug: RC148 plus Telisotuzumab adizutecan
Dose1 Telisotuzumab adizutecan plus BevacizumabActive comparatorNot described
Receives: Drug: Telisotuzumab adizutecan plus Bevacizumab
Dose3 RC148 plus Dose2 Telisotuzumab adizutecan plus 5-FUExperimentalNot described
Receives: Drug: RC148 plus Telisotuzumab adizutecan
Dose4 RC148 plus Dose2 Telisotuzumab adizutecan plus 5-FUExperimentalNot described
Receives: Drug: RC148 plus Telisotuzumab adizutecan
Dose2 Telisotuzumab adizutecan plus Bevacizumab plus 5-FUActive comparatorNot described
Receives: Drug: Telisotuzumab adizutecan plus Bevacizumab

What is being measured

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

  1. ORR as assessed by the Investigator per RECIST v1.1

    Measured: From randomization date until disease progression, lost to follow-up, withdrawal of informed consent or death, assessed up to approximately 24 months

  2. The incidence and severity of AEs, vital signs, physical examinations, ECGs, and laboratory test

    Measured: Screening through 120 days after the last dose of RC148/telisotuzumab adizutecan/bevacizumab or 28 days after the last dose of 5-FU/LV, whichever is late

Secondary outcomes (16)

  1. RC148 and Telisotuzumab adizutecan concentrations at each time-point post-dosing

    Measured: 24 months

  2. Maximum concentration (Cmax) of RC148 and Telisotuzumab adizutecan

    Measured: 24 months

  3. Time to Cmax (Tmax) of RC148 and Telisotuzumab adizutecan

    Measured: 24 months

  4. Area under the concentration-time curve for a dosing interval (AUCtau) of RC148 and Telisotuzumab adizutecan

    Measured: 24 months

  5. Area under the concentration-time curve extrapolated to infinity (AUCinf) of RC148 and Telisotuzumab adizutecan

    Measured: 24 months

  6. Elimination half-life (t1/2) of RC148 and Telisotuzumab adizutecan

    Measured: 24 months

  7. Incidence of ADA for RC148 and Telisotuzumab adizutecan

    Measured: 24 months

  8. Onset timing of ADA for RC148 and Telisotuzumab adizutecan

    Measured: 24 months

  9. Duration of ADA for RC148 and Telisotuzumab adizutecan

    Measured: 24 months

  10. Titers of ADA for RC148 and Telisotuzumab adizutecan

    Measured: 24 months

  11. Incidence of NAb for RC148 and Telisotuzumab adizutecan

    Measured: 24 months

  12. PFS as assessed by the Investigator per RECIST v1.1

    Measured: From randomization date until disease progression, lost to follow-up, withdrawal of informed consent or death, assessed up to approximately 24 months

  13. TTR as assessed by the Investigator per RECIST v1.1

    Measured: From randomization date until disease progression, lost to follow-up, withdrawal of informed consent or death, assessed up to approximately 24 months

  14. DCR as assessed by the Investigator per RECIST v1.1

    Measured: From randomization date until disease progression, lost to follow-up, withdrawal of informed consent or death, assessed up to approximately 24 months

  15. DoR as assessed by the Investigator per RECIST v1.1

    Measured: From randomization date until disease progression, lost to follow-up, withdrawal of informed consent or death, assessed up to approximately 24 months

  16. OS as assessed by the Investigator per RECIST v1.1

    Measured: From randomization date until lost to follow-up, withdrawal of informed consent or death, assessed up to approximately 24 months

Timeline

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

  1. First posted26 Oct 2026
  2. Study startNov 2026 (estimated)
  3. Primary completionJul 2028 (estimated)
  4. Study completionJan 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 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
412 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07895355
Sponsor's protocol ID
RC148-A202
Status last verified
Oct 2026
First submitted
12 Oct 2026
Last updated
26 Oct 2026
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing RC148 plus Telisotuzumab adizutecan and Telisotuzumab adizutecan plus Bevacizumab in people with Patients With Unresectable Colorectal Cancer Requiring First-Line or Second-Line Therapy, run by RemeGen Co., Ltd. at 1 site in China.

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 30 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: opening soon, as of the sponsor's last update on 26 Oct 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 China. 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 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 Jiang Guo (010-65384976, jiang.guo@remegen.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

ORR as assessed by the Investigator per RECIST v1.1 (time frame: From randomization date until disease progression, lost to follow-up, withdrawal of informed consent or death, assessed up to approximately 24 months). 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 NCT07895355.

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 26 Oct 2026.

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