A Phase 2 interventional study of Telisotuzumab Adizutecan and Fluorouracil in Metastatic Colorectal Cancer, sponsored by AbbVie. Recruiting at 82 sites in 15 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-10-27.
Sponsored by AbbVie · Phase 2, Interventional, and Treatment
Among 206 studies testing oxaliplatin in Colorectal Neoplasms — 21 open to participants now, 25 under way, 6 of them phase 3. Oxaliplatin · Colorectal Neoplasms.
Among the 206 studies testing oxaliplatin in Colorectal Neoplasms, this one is the 21st largest by planned enrollment of the 183 interventional ones that give a count, is one of 3 that started in 2025, is one of 110 in phase 2, reaches primary completion later than 21 of the 24 other live ones, and was the 200th registered.
6,541 studies on the registry are indexed under Colorectal Neoplasms; 1,667 are open to participants now.
Browse Colorectal Neoplasms studies →21 of the 206 studies testing oxaliplatin in Colorectal Neoplasms are open now, in 12 countries. Recruiting first, the newest first:
Sun Yat-sen University · Sites in China
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins · Sites in United States
Sunshine Guojian Pharmaceutical (Shanghai) Co., Ltd. · Sites in China
Cancer Institute and Hospital, Chinese Academy of Medical Sciences · Sites in China
Shanghai Zhongshan Hospital · Sites in China
By country, each count listing its studies:
Oxaliplatin: first FDA approval 2002 (ELOXATIN). What it is approved for, and how studies give it, is on its page →
Of the 1,185 Colorectal Neoplasms studies recruiting now, 769 (65%) set no upper age limit and 265 (22%) stop at 75 or younger; 48 take children under 18; 123 take healthy volunteers.
This study: 18 Years and older · all sexes · no healthy volunteers.
The full table on the hub →This tab as a report to print or save as PDF → With an account.
206 studies; the count open now beside each. This study's row is marked.
A study in two phases is counted once above. Listed by phase, each with its combined phases: Phase 1 45 · Phase 2 130 · Phase 3 40 · Phase 4 5
First in 1998; this study’s year is marked. 3 started in 2025.
This study's planned enrollment of 390 is above the median of 76 across 4,800 interventional studies indexed under Colorectal Neoplasms.
Median enrollment 50 across the 183 interventional studies. Of the 134 that completed or were terminated, 35 (26%) have results posted.
This tab as a report to print or save as PDF → With an account.
35 of 206 have an industry lead sponsor. The 10 most frequent:
AbbVie is the lead sponsor of 973 studies on the registry; 133 are open to participants now.
Of its 357 completed or terminated interventional studies of FDA-regulated products, 214 (60%) have results posted.
16 studies in Colorectal Neoplasms by AbbVie: 4 open now, 8 under way, 1 of them phase 3. Of 8 finished, 2 (25%) have results posted.
Among the 16 studies in Colorectal Neoplasms by AbbVie, this one is the 3rd largest by planned enrollment, is one of 2 that started in 2025, is one of 5 in phase 2, and was the 13th registered.
AbbVie’s Colorectal Neoplasms studies by the year they started, since 2013.
4 of the studies testing oxaliplatin in Colorectal Neoplasms that are under way reach primary completion within a year, 0 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT07233850Shenyang Sunshine Pharmaceutical Co., LTD.A Phase II Clinical Study Evaluating SSGJ-706 in Combination Therapy for Advanced Gastrointestinal Cancers | 2026-12 |
| NCT07229846Yanqiao ZhangA Single-arm, Single-center, Phase II Clinical Study of Aipalolitovorelizumab (QL1706) Combined With Bevacizumab and Standard Chemotherapy as First-line Treatment for MSS/pMMR Metastatic Colorectal Cancer With BRAF V600E Mutation | 2027-02 |
| NCT07570914Tianjin Medical University Cancer Institute and HospitalHepatic Arterial Infusion of Liposomal Irinotecan Plus Oxaliplatin and Capecitabine as Adjuvant Therapy for Colorectal Cancer Liver Metastases | 2027-05-30 |
| NCT06269978Arjun MittraIntraperitoneal Oxaliplatin and Fluorouracil for the Treatment of Patients With Peritoneal Metastases From Colorectal Cancer | 2027-09-30 |
Among the 206 studies testing oxaliplatin in Colorectal Neoplasms, from their registry updates:
Among AbbVie’s 16 in Colorectal Neoplasms:
This tab as a report to print or save as PDF → With an account.
CRC is the third most common type of cancer diagnosed worldwide with developed countries at highest risk. The purpose of this study is to assess adverse events and change in disease activity when telisotuzumab adizutecan is given in combination with oxaliplatin, fluorouracil (5FU), leucovorin (LV) (FOLFOX), and bevacizumab or panitumumab.
Telisotuzumab adizutecan is an investigational drug being developed for the treatment of mCRC. Fluorouracil and leucovorin are drugs approved for the treatment of mCRC. This study will be divided into two stages, with the first stage treating participants with increasing doses of telisotuzumab adizutecan with FOLFOX and bevacizumab or 5FU/LV and panitumumab until the dose reached is tolerable and expected to be efficacious. Participants will then be randomized into 3 groups called treatment arms where one group will receive one of two optimized doses of telisotuzumab adizutecan from the dose escalation phase with FOLFOX and bevacizumab or 5FU/LV and panitumumab, or a comparator of FOLFOX and bevacizumab or panitumumab. Approximately 390 adult participants with mCRC will be enrolled in the study in 100 sites worldwide.
In the dose escalation stage participants will be treated with increasing intravenous (IV) doses of telisotuzumab adizutecan with FOLFOX and bevacizumab or 5FU/LV and panitumumab until the dose reached is tolerable and expected to be efficacious. In the dose optimization stage participants will be receive FOLFOX or receive 5FU/LV, but with one of two optimized doses of telisotuzumab adizutecan, or a comparator of FOLFOX and bevacizumab/pantitumumab. The study will run for a duration of approximately 6 years.
There may be higher treatment burden for participants in this trial compared to their standard of care. Participants will attend regular visits during the study at an approved institution (hospital or clinic). The effect of the treatment will be frequently checked by medical assessments, blood tests, questionnaires and side effects.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
A scale of how much an illness limits everyday activity. For people being assessed to join a study, scores run from 0 (fully active) to 4; lower is more active.
Studies most often ask for 0–1 or 0–2. Your doctor gives the score; the WHO scale uses the same steps. The full scale also has 5, which records death.
The amount of disease can be tracked with a defined measurement, so the study can see whether it shrinks or grows. It might be a tumour measured on a scan or, in some blood cancers such as myeloma, a marker measured in blood or urine.
The criteria or the study team say which measurement counts — having no tumour visible on a scan does not by itself rule you out.
The standard rules for measuring tumours on CT or MRI scans, to tell whether a cancer is shrinking, stable or growing during treatment.
“Measurable disease per RECIST 1.1” usually means at least one tumour 10 mm or more at its longest on a CT scan, or a lymph node 15 mm or more across its short axis.
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.
ECOG performance status
A scale of how much an illness limits everyday activity. For people being assessed to join a study, scores run from 0 (fully active) to 4; lower is more active.
Studies most often ask for 0–1 or 0–2. Your doctor gives the score; the WHO scale uses the same steps. The full scale also has 5, which records death.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Measurable disease
The amount of disease can be tracked with a defined measurement, so the study can see whether it shrinks or grows. It might be a tumour measured on a scan or, in some blood cancers such as myeloma, a marker measured in blood or urine.
The criteria or the study team say which measurement counts — having no tumour visible on a scan does not by itself rule you out.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
RECIST
The standard rules for measuring tumours on CT or MRI scans, to tell whether a cancer is shrinking, stable or growing during treatment.
“Measurable disease per RECIST 1.1” usually means at least one tumour 10 mm or more at its longest on a CT scan, or a lymph node 15 mm or more across its short axis.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Cancer (malignancy)
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Metastases
Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Participants will receive various doses of telisotuzumab adizutecan in combination with a fixed dose of fluorouracil, leucovorin, and oxaliplatin (FOLFOX) and bevacizumab as part of the approximately 6 year study duration.
Drug: Telisotuzumab Adizutecan · Drug: Fluorouracil · Drug: Oxaliplatin · Drug: Leucovorin · Drug: Bevacizumab
Participants will receive the high dose of telisotuzumab adizutecan determined in the dose expansion arm in combination with a fixed dose of FOLFOX and bevacizumab as part of the approximately 6 year study duration.
Drug: Telisotuzumab Adizutecan · Drug: Fluorouracil · Drug: Oxaliplatin · Drug: Leucovorin · Drug: Bevacizumab
Participants will receive the low dose of telisotuzumab adizutecandetermined in the dose expansion arm in combination with a fixed dose of FOLFOX and bevacizumab as part of the approximately 6 year study duration.
Drug: Telisotuzumab Adizutecan · Drug: Fluorouracil · Drug: Oxaliplatin · Drug: Leucovorin · Drug: Bevacizumab
Participants will receive a fixed dose of FOLFOX and bevacizumab as part of the approximately 6 year study duration.
Drug: Fluorouracil · Drug: Oxaliplatin · Drug: Leucovorin · Drug: Bevacizumab
Participants will receive various doses of telisotuzumab adizutecan in combination with a fixed dose of fluorouracil (5-FU) and leucovorin (LV) and panitumumab as part of the approximately 6 year study duration.
Drug: Telisotuzumab Adizutecan · Drug: Fluorouracil · Drug: Leucovorin · Drug: Panitumumab
Participants will receive the high dose of telisotuzumab adizutecan determined in the dose expansion arm in combination with a fixed dose of 5-FU/LV and panitumumab as part of the approximately 6 year study duration.
Drug: Telisotuzumab Adizutecan · Drug: Fluorouracil · Drug: Leucovorin · Drug: Panitumumab
Participants will receive the low dose of telisotuzumab adizutecan determined in the dose expansion arm in combination with a fixed dose of 5-FU/LV and panitumumab as part of the approximately 6 year study duration.
Drug: Telisotuzumab Adizutecan · Drug: Fluorouracil · Drug: Leucovorin · Drug: Panitumumab
Participants will receive a fixed dose of FOLFOX and panitumumab as part of the approximately 6 year study duration.
Drug: Fluorouracil · Drug: Oxaliplatin · Drug: Leucovorin · Drug: Panitumumab
Intravenous (IV) Infusion
IV Infusion; IV Injection
IV Infusion
IV Infusion; IV Injection
IV Infusion
IV Infusion
Objective Response (OR) as Assessed by the Investigator confirmed complete response (CR) or partial response (PR) as assessed by the investigator per response evaluation criteria in solid tumors (RECIST), version 1.1.
OR is defined as confirmed CR or PR as assessed by the investigator per RECIST, version 1.1.
Time frame: Up to 24 Weeks
Number of Participants with Adverse Events (AE)s
An adverse event is defined as any untoward medical occurrence in a participant or clinical investigation participant administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment.
Time frame: Up to Approximately 6 Years
Progression-Free Survival (PFS) as Assessed by the Investigator
PFS is defined as the time from the first dose of study treatment to the first occurrence of radiographic progression based on RECIST version 1.1 as determined by the investigator or death from any cause, whichever occurs earlier.
Time frame: Up to 22 Months
Duration of Response (DOR) as Assessed by the investigator
DOR is defined as the time from the first documented CR or PR to the first occurrence of radiographic progression per RECIST v1.1 as determined by the investigator or death from any cause, whichever occurs first.
Time frame: Up to 14 Months
Overall Survival (OS)
OS is defined as the time from first dose of study treatment to the event of death from any cause.
Time frame: Up to Approximately 6 Years
Disease Control (DC) as Assessed by the Investigator
DC is defined as best overall response of confirmed CR or confirmed PR, or stable disease (SD) based on RECIST, version 1.1 as determined by the investigator.
Time frame: Up to Approximately 6 Years
Plan to share: Yes — AbbVie is committed to responsible clinical trial data sharing. This includes access to anonymized, individual and trial-level data (analysis data sets), as well as other information.
Supporting information: Study protocol, Statistical analysis plan
Time frame: For details on when studies are available for sharing, visit https://vivli.org/ourmember/abbvie/
Access criteria: To learn more about the process, or to submit a request, visit the following link https://www.abbvieclinicaltrials.com/hcp/data-sharing/
Data sharing details ↗ · vivli.org
No publications or documents are linked to this record.
Started Apr 2025 (actual). Primary completion is estimated for Mar 2028, 35 months after the start.
Of 120 industry-sponsored phase 2 interventional studies under Colorectal Neoplasms, half reached primary completion within 34 months of starting (the median), counting those still running; a quarter within 26 and three quarters within 72. This study's planned 35 months is close to that.
Counting every sponsor, half of 618 studies reached it within 49 months; a quarter within 31 and three quarters within 75.
How these figures are worked out, and which studies are left out of them.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.
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Studies of the drugs tested here: Telisotuzumab adizutecan · Oxaliplatin · Bevacizumab · Panitumumab