Description:
This is a Phase I/II, open-label study of IMMU-130 administered in 21-day treatment cycles,
once or twice weekly for 2 consecutive weeks followed by one week of rest to patients with
metastatic colorectal cancer who have been previously treated with at least one prior
irinotecan-containing regimen. The study is being done to evaluate whether the study drug is
safe and tolerable at different dose levels with these dosing schedules and to obtain
preliminary information on its efficacy.
Title
- Brief Title: Dose Finding Study of Once or Twice Weekly IMMU-130 in Metastatic Colorectal Cancer
- Official Title: A Phase I/II Study of Once or Twice Weekly IMMU-130 (hMN-14-SN38, Antibody-Drug Conjugate) in Patients With Colorectal Cancer.
Clinical Trial IDs
- ORG STUDY ID:
IM-T-IMMU-130-02
- NCT ID:
NCT01605318
Conditions
- Metastatic Colorectal Cancer
- Colon Cancer
- Rectal Cancer
Interventions
| Drug | Synonyms | Arms |
|---|
| IMMU-130 | hMN14-SN38, Labetuzumab-SN38, Antibody-Drug Conjugate | IMMU-130 |
Purpose
This is a Phase I/II, open-label study of IMMU-130 administered in 21-day treatment cycles,
once or twice weekly for 2 consecutive weeks followed by one week of rest to patients with
metastatic colorectal cancer who have been previously treated with at least one prior
irinotecan-containing regimen. The study is being done to evaluate whether the study drug is
safe and tolerable at different dose levels with these dosing schedules and to obtain
preliminary information on its efficacy.
Trial Arms
| Name | Type | Description | Interventions |
|---|
| IMMU-130 | Experimental | All patients receive IMMU-130 administered in 21-day treatment cycles consisting of once or twice weekly for 2 consecutive weeks followed by a 1-week rest period. Treatment can be continued in the absence of unacceptable toxicity for a period of up to 8 cycles until the first documentation of Progressive Disease by CT (physician discretion), but must terminate study treatment upon the second documentation of Progressive Disease. | |
Eligibility Criteria
Inclusion Criteria:
- Male or female patients, ≥ 18 years of age, able to understand and give written
informed consent.
- Histologically or cytologically confirmed colorectal adenocarcinoma.
- Stage IV (metastatic) disease.
- Previously treated with at least one prior irinotecan-containing regimen for
colorectal cancer.
- Adequate performance status (ECOG 0 or 1). (Appendix 1)
- Expected survival > 6 months.
- CEA plasma levels > 5 ng/mL.
- Measurable disease by CT or MRI.
- At least 4 weeks beyond treatment (chemotherapy, immunotherapy and/or radiation
therapy) or major surgery and recovered from all acute toxicities.
- At least 2 weeks beyond corticosteroids.
- Adequate hematology without ongoing transfusional support (hemoglobin > 9 g/dL, ANC >
1,500 per mm3, platelets > 100,000 per mm3).
- Adequate renal and hepatic function (creatinine ≤ 1.5 x IULN, bilirubin ≤ IULN, AST
and ALT ≤ 3.0 x IULN or 5 x IULN if know liver metastases).
- Otherwise, all toxicity at study entry ≤ Grade 1 by NCI CTC v4.0.
Exclusion Criteria:
- Women who are pregnant or lactating.
- Women of childbearing potential and fertile men unwilling to use effective
contraception during study until conclusion of 12-week post-treatment evaluation
period.
- Patients with Gilbert's disease or known CNS metastatic disease.
- Patients with CEA plasma levels > 1000 ng/mL are excluded during dose escalation, but
may be included after the MTD is determined.
- Presence of bulky disease (defined as any single mass > 10 cm in its greatest
dimension).
- Patients with active ≥ grade 2 anorexia, nausea or vomiting, and/or signs of
intestinal obstruction.
- Patients with non-melanoma skin cancer or carcinoma in situ of the cervix are
eligible, while patients with other prior malignancies must have had at least a 3-year
disease-free interval.
- Patients known to be HIV positive, hepatitis B positive, or hepatitis C positive.
- Known history of unstable angina, MI, or CHF present within 6 months or clinically
significant cardiac arrhythmia (other than stable atrial fibrillation) requiring
anti-arrhythmia therapy.
- Known history of clinically significant active COPD, or other moderate-to-severe
chronic respiratory illness present within 6 months.
- Infection requiring intravenous antibiotic use within 1 week.
- Other concurrent medical or psychiatric conditions that, in the Investigator's
opinion, may be likely to confound study interpretation or prevent completion of study
procedures and follow-up examinations.
| Maximum Eligible Age: | N/A |
| Minimum Eligible Age: | 18 Years |
| Eligible Gender: | All |
| Healthy Volunteers: | No |
Primary Outcome Measures
| Measure: | Evaluate the safety and tolerability of IMMU-130 |
| Time Frame: | Every 3 months |
| Safety Issue: | |
| Description: | |
Secondary Outcome Measures
| Measure: | Obtain information on efficacy |
| Time Frame: | During treatment and the changes at 4, 8 and 12 weeks after treatment |
| Safety Issue: | |
| Description: | Efficacy will be evaluated from CT scans using RECIST criteria |
Details
| Phase: | Phase 1/Phase 2 |
| Primary Purpose: | Interventional |
| Overall Status: | Withdrawn |
| Lead Sponsor: | Gilead Sciences |
Trial Keywords
- metastatic colorectal cancer
- colon cancer
- rectal cancer
- previously treated
Last Updated
August 19, 2021
