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Metastatic Colorectal CancerPhase 2/3TROPHIT1NCT06243393

Sacituzumab Govitecan in Metastatic Colorectal Cancer

A Phase 2/3 study testing Sacituzumab Govitecan (SG) and Physicians Choice (PhC). in people with Metastatic Colorectal Cancer, run by University Hospital Heidelberg at 1 site in Germany.

Recruiting

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

Sites and contacts
Official record
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Trial summary

This is a Phase: II/III, open-label, multicenter (at least four centers in Germany) study of Sacituzumab Govitecan (SG) in metastatic colorectal cancer patients who are refractory to at least two lines of standard of care chemotherapy and not eligible for local therapy. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Metastatic Colorectal Cancer
What is being tested?
Sacituzumab Govitecan (SG) and Physicians Choice (PhC).
Could I receive a placebo?
No, everyone receives an active treatment
How many people
80 participants
Where
1 siteGermany
Study dates
19 Apr 2024to 1 Feb 2029
Phase
Phase 2/3
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 meeting all of the following criteria are considered for admission to the trial:
  • Diagnosis of UICC Stage IV mCRC, not eligible for local therapy
  • Women or men aged ≥ 18 years, no upper age limit
  • ECOG performance status ≤2
  • Patients must have failed standard therapy or were intolerable towards standard therapy which must include fluoropyrimidine, oxaliplatin and irinotecan. (Targeted therapies (in combination with chemotherapy) including antiangiogenic monoclonal antibody/fusion protein/small molecule (e.g. bevacizumab, aflibercept, ramucirumab) and anti-EGFR antibody (e.g. Cetuximab, Panitumumab) are allowed as previous therapies.)
  • No Irinotecan treatment within the last 6 months. Patients that received Irinotecan treatment more than 6 months prior to inclusion, must have been responsive to Irinotecan induction therapy (i.e., patients previously exposed to induction chemotherapy containing irinotecan must have presented CR or PR or else SD at least 3 months or at initial response assessment).
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  • At least one measurable lesion according to RECIST 1.1 that can be accurately assessed at screening by computed tomography or magnetic resonance imaging and is suitable for repeated assessment or available CT scan of thorax and abdomen not older than 30 days before start of treatment (day 1 of cycle 1).
  • Written informed consent
  • Non-pregnant and non-nursing women of childbearing potential (WOCBP) must have a negative serum or urine pregnancy test within a sensitivity of at least 25 mIU/mL within 72 hours prior to start of study treatment. A woman is considered of childbearing potential, i.e. fertile, following menarche and until becoming post-menopausal unless permanently sterile.
  • Permanent sterilization methods include hysterectomy, bilateral salpingectomy and bilateral oophorectomy.
  • Post-menopausal or evidence of non-childbearing status is defined within this clinical trial:
  • Amenorrhea for at least 12 consecutive months without an alternative medical cause following cessation of exogenous hormonal treatments.
  • Chemotherapy-induced menopause with >1 year interval since last menses
  • Surgical sterilisation
  • WOCBP are to be advised using two effective methods of birth control to avoid pregnancy throughout the study and for at least 6 months after the last dose of IMP. This includes effective contraception methods that can achieve a failure rate of less than 1% per year (e.g. hormonal contraceptive and condom, IUD/IUS and condom) or sterilization, resulting in a failure rate less than 1% per year.
  • Fertile men should not donate sperm and must be willing and able to use two effective methods of birth control (e.g latex condoms plus hormonal contraception in their partner) throughout the study and for at least 6 months after the last dose of IMP, if their sexual partners are WOCBP (acceptable methods see above). A man is considered fertile after puberty unless permanently sterile by bilateral orchidectomy.

Who cannot join

  • Patients meeting any of the following criteria are not eligible for the trial:
  • Patient with a known hypersensitivity to any of the excipients of sacituzumab govitecan
  • Participation in other clinical trials involving an investigational drug(s) (Phases 1-4) or observation period of competing trials, respectively within 4 weeks prior to study entry.
  • Patients participating in observational studies are eligible.
  • Taking medications that may interfere with SN-38 metabolism.
  • Have had a prior anticancer biologic agent within 2 weeks prior to enrollment or have had prior chemotherapy, targeted therapy, or radiation therapy within 2 weeks prior to enrollment AND have not recovered (ie, ≥ Grade 2 is considered not recovered) from AEs at the time of study entry.
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  • Have not recovered (ie, ≥ Grade 2 is considered not recovered) from AEs due to a previously administered agent.
  • Note: patients with any grade neuropathy or alopecia are an exception to this criterion and will qualify for the study.
  • Note: if patients received major surgery, they must have recovered adequately from the toxicity and/or complications from the intervention prior to starting therapy.
  • Have an active second malignancy. Note: patients with a history of malignancy that have been completely treated, with no evidence of active cancer for 3 years prior to enrollment, or patients with surgically cured tumors with low risk of recurrence (eg, nonmelanoma skin cancer, histologically confirmed complete excision of carcinoma in situ, or similar) are allowed to enroll.
  • History of significant cardiovascular disease ( NYHA ≥ III)
  • Clinical signs of active severe infection with or without requiring antibiotics.
  • Have known history of HIV-1 or 2 (or positive HIV-1/2 antibody, if done at screening) with detectable viral load
  • Have active hepatitis B virus (HBV) or hepatitis C virus (HCV). In patients with a history of HBV or HCV, patients with detectable viral loads will be excluded.
  • Patients who test positive for hepatitis B surface antigen (HBsAg). Patients who test positive for hepatitis B core antibody (anti-HBc) will require HBV DNA by quantitative polymerase chain reaction (PCR) for confirmation of active disease.
  • Patients who test positive for HCV antibody. Patients who test positive for HCV antibody will require HCV RNA by quantitative PCR for confirmation of active disease. Patients with a known history of HCV or a positive HCV antibody test will not require a HCV antibody at screening and will only require HCV RNA by quantitative PCR for confirmation of active disease.
  • Inadequate bone marrow, renal, and hepatic function defined by laboratory tests within 14 days prior to study treatment (growth factor support is not allowed within 14 days prior to baseline labs; Hemoglobin <9 g/dl, Neutrophil count <1500/ l, Platelet count <100000/l, Total bilirubin >1.5 times the institutional upper limit of normal (ULN, except patients with Gilbert Syndrome, there >3.0 mg/dl), Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) >2.5 ULN; subjects with documented liver metastases may have an AST and ALT of >5.0 ULN and serum albumin <3 g/dl, Estimated creatinine clearance calculated creatinine clearance <30 ml/minute according to the Cockcroft and Gault formula)
  • Known microsatellite instable (MSI-H) / MMR-protein deficient (dMMR) colorectal cancer.
  • Any medical or other condition which, in the opinion of the Investigator, causes the subject to be medically unfit to receive sacituzumab govitecan, or unsuitable for any other reason
  • Pregnancy and lactation
  • Inability of patient to understand character and consequences of the clinical trial

Trial locations and contacts

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

Germany1 site, 1 recruiting

  • University Hospital Heidelberg

    Heidelberg, Baden-Wurttemberg, 69124

    Bruno Köhler, Dr., 06221 ext. 560, bruno.koehler@nct-heidelberg.de

    Recruiting

Other trials in Germany

About this study

Official title: A Randomized, Open Label, Multicenter Phase II/III Trial of Sacituzumab Govitecan Compared to Standard of Care in Metastatic, Refractory Colorectal Cancer Patients

This is a Phase: II/III, open-label, multicenter (at least four centers in Germany) study of Sacituzumab Govitecan (SG) in metastatic colorectal cancer patients who are refractory to at least two lines of standard of care chemotherapy and not eligible for local therapy. There is no upper limit in the previous therapy lines. Patients must have documented progression or intolerability to combination chemotherapy including 5-fluoruacil or its prodrugs and derivates, Oxaliplatin and Irinotecan or a combination of the aforementioned. Previous biologicals/antibodies/small molecules including anti-EGFR and anti-VEGF directed therapies are allowed but not mandatory to meet eligibility. Trifluridin/Tipiracil (TAS102) or Regorafenib are allowed but not mandatory as previous therapies for PART I and PART II of the trial. All patients must have a documented Irinotecan-free interval of at least 6 months to be eligible for the study.

The study consists of two parts:

Read more

PART I: a single arm run in phase, treating 20 patients with Sacituzumab Govitecan (SG) PART II: a 1:1 randomized open label phase, comparing 30 patients treated with SG vs. 30 patients treated according to Physicians Choice (PhC). Crossover to the experimental arm (SG) is allowed in case of progression in the standard arm (PhC).

PART II will only be started if significant clinical efficacy and activity is observed in PART I.

Being tested
Sacituzumab Govitecan (SG), Physicians Choice (PhC).
Medical subject headings
Colorectal Neoplasms

What participants receive

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

  • Sacituzumab Govitecan (SG)Drug

    Treatment with Sacituzumab Govitecan (SG)

  • Physicians Choice (PhC).Drug

    Treatment according to oncologic guidelines.

Study groups in NCT06243393
Study groupRoleWhat they receive
Sacituzumab Govitecan (SG)ExperimentalTreatment with Sacituzumab Govitecan (SG) .
Receives: Drug: Sacituzumab Govitecan (SG)
Physicians Choice (PhC).Active comparatorTreatment according to oncologic guidelines.
Receives: Drug: Physicians Choice (PhC).

What is being measured

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

  1. Progression Free Survival (PFS)

    Progression Free Survival (PFS): as the time from randomization into the study to time of progression of the disease or death from any cause, whatever occurs first. Patients without an applicable event are censored on the last date of follow-up.

    Measured: time from randomization into the study to time of progression of the disease or death from any cause, whatever occurs first, assessed on average up to 1 year

Secondary outcomes (1)

  1. Overall Survival (OS)

    Overall Survival (OS): as time from randomization until death or end of study (EOS). Patients without an applicable event are censored on the last date of follow-up.

    Measured: time from randomization into the study to time of death or end of study (EOS), assessed on average up to 1 year

Timeline

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

  1. First posted6 Feb 2024
  2. Study start19 Apr 2024
  3. Primary completion1 Aug 2028 (estimated)
  4. Study completion1 Feb 2029 (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 2/3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
80 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06243393
Sponsor's protocol ID
NCT_GI_BCK_01
Other IDs
2023-509771-17-00, AIO-KRK-0124/ass, 2023
Acronym
TROPHIT1
Status last verified
Jul 2024
First submitted
24 Jan 2024
Last updated
10 Jul 2024
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Questions about this trial

What is this clinical trial studying?

A Phase 2/3 study testing Sacituzumab Govitecan (SG) and Physicians Choice (PhC). in people with Metastatic Colorectal Cancer, run by University Hospital Heidelberg at 1 site in Germany.

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 21 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 10 Jul 2024. 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 Germany. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

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?

Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Progression Free Survival (PFS) (time frame: time from randomization into the study to time of progression of the disease or death from any cause, whatever occurs first, assessed on average up to 1 year). 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 NCT06243393.

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 10 Jul 2024.

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