Solid Tumors Clinical Trial
Official title:
A Phase 1 Dose Escalation Study of OMP-59R5 in Subjects With Solid Tumors
NCT number | NCT01277146 |
Other study ID # | 59R5-001 |
Secondary ID | |
Status | Completed |
Phase | Phase 1 |
First received | |
Last updated | |
Start date | December 2010 |
Est. completion date | May 2013 |
Verified date | September 2020 |
Source | Mereo BioPharma |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
This is an open-label Phase 1 dose escalation study of OMP-59R5 in subjects with previously
treated solid tumors for which there is no remaining standard curative therapy and no therapy
with a demonstrated survival benefit. Up to 44 subjects will be enrolled at up to 2 centers.
Subjects will be assessed for safety, immunogenicity, pharmacokinetics, biomarkers, and
efficacy. No formal interim analyses will be performed.
Prior to enrollment, subjects will undergo screening to determine study eligibility. Upon
enrollment, subjects will receive intravenous (IV) infusions of OMP-59R5 at a assigned dosing
schedule for 56 days. After 56 days, subjects will be assessed for disease status. If there
is no evidence of disease progression or if the tumor is smaller, then subjects may continue
to receive IV infusions of OMP-59R5 every week until disease progression.
Dose escalation will be conducted to determine the maximum tolerated dose (MTD). No dose
escalation or reduction will be allowed within a dose cohort. The first 2 subjects enrolled
in a cohort will not be treated on the same day. The dose may be administered at any time
during the day. Three subjects will be treated at each dose level if no dose-limiting
toxicities (DLTs) are observed. The first 2 subjects in each cohort will not be started on
OMP-59R5 on the same day. If 1 of 3 subjects experiences a DLT, that dose level will be
expanded to 6 subjects. If 2 or more subjects experience a DLT, no further subjects will be
dosed at that level and 3 additional subjects will be added to the preceding dose cohort
unless 6 subjects have already been treated at that dose level. Subjects will be assessed for
DLTs from the time of the first dose through 28 days. Dose escalation for newly enrolled
subjects, if appropriate, will occur after all subjects in a cohort have completed their Day
28 DLT assessment. Subjects with stable disease or a response at Day 56 will be allowed to
continue to receive weekly doses of OMP-59R5 until disease progression. An additional 14
subjects will be enrolled at the highest dose level that result in <2 of the 6 subjects
experiencing a DLT.
Status | Completed |
Enrollment | 42 |
Est. completion date | May 2013 |
Est. primary completion date | March 2013 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 90 Years |
Eligibility |
Inclusion Criteria: 1. Subjects must have a histologically confirmed malignancy that is metastatic or unresectable for which there is no remaining standard curative therapy and no therapy with a demonstrated survival benefit. In addition, subjects must have a tumor that is at least 1 cm in a single dimension and is radiographically apparent on CT or MRI. 2. Subjects must have received their last chemotherapy, biologic, or investigational therapy at least 4 weeks prior to enrollment, 6 weeks if the last regimen included BCNU or mitomycin C. 3. Age >18 years 4. ECOG performance status <2 (see Appendix B) 5. Life expectancy of more than 3 months 6. Subjects must have normal organ and marrow function as defined below: - Absolute neutrophil count >1000/mL - Hemoglobin >9.0 g/dL - Platelets >100,000/mL - Total bilirubin <1.5 X institutional upper limit of normal (ULN) - AST (SGOT) and ALT (SGPT) < 3 X institutional ULN (for subjects with hepatic metastases < 5 X institutional ULN) - PT and PTT within 1.5 X institutional ULN - Creatinine <1.5 X institutional ULN OR - Creatinine clearance >60 mL/min/1.73 m2 for subjects with creatinine levels above institutional normal 7. Women of childbearing potential must have had a prior hysterectomy or have a negative serum pregnancy test and be using adequate contraception prior to study entry and must agree to use adequate contraception from study entry through at least 6 months after discontinuation of study drug. Men must also agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry and from study entry through at least 6 months after discontinuation of study drug. Should a woman enrolled in the study or a female partner of a man enrolled in the study become pregnant or suspect she is pregnant while participating in this study or within 6 months after discontinuation of study, she should inform the Investigator immediately. 8. Ability to understand and the willingness to sign a written informed consent document Exclusion Criteria: 1. Subjects receiving any other investigational agents 2. Subjects with brain metastases (subjects must have a CT scan or MRI of the head within 28 days prior to enrollment to rule out brain metastases), uncontrolled seizure disorder, or active neurologic disease 3. History of a significant allergic reaction attributed to humanized or human monoclonal antibody therapy 4. Significant intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements 5. Pregnant women or nursing women 6. Subjects with known HIV infection 7. Known bleeding disorder or coagulopathy 8. Subjects receiving heparin, warfarin, or other similar anticoagulants, except for subjects on low molecular weight heparin for DVT/PE prophylaxis. Note: Subjects may be receiving low-dose aspirin and/or non-steroidal anti-inflammatory agents. 9. New York Heart Association Classification II, III, or IV 10. Subjects with a blood pressure of >140/90 mmHg. The blood pressure must be taken three times 10 minutes apart. Subjects taking antihypertensive medications must be taking = 2 medications to obtain this level of blood pressure control. 11. Subjects with EKG evidence of ischemia or = Grade 2 ventricular arrhythmia, subjects who have a history of acute myocardial infarction within 6 months, or subjects with unstable angina. 12. Subjects with known clinically significant gastrointestinal disease including, but not limited to, inflammatory bowel disease. 13. Subjects with known clinically significant gastrointestinal disease including, but not limited to, inflammatory bowel disease. 14. Subjects with >1 grade 1 diarrhea. |
Country | Name | City | State |
---|---|---|---|
United States | University of Michigan Comprehensive Cancer Center | Ann Arbor | Michigan |
United States | South Texas Accelerated Research Therapeutics | San Antonio | Texas |
Lead Sponsor | Collaborator |
---|---|
OncoMed Pharmaceuticals, Inc. |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | To determine the safety of OMP-59R5 in subjects with previously treated solid tumors | The number of patients experiencing Adverse Events will be reported. | continuous | |
Secondary | To determine the pharmacokinetics of OMP-59R5 in subjects with previously treated solid tumors | The half-life, volume of distribution, and clearance will be determined | First 8 doses and following treatment termination | |
Secondary | To determine the immunogenicity of OMP-59R5 in subjects with previously treated solid tumors | The rate of neutralizing antibodies will be determined | continuous | |
Secondary | To assess the preliminary efficacy of OMP-59R5 in subjects with previously treated solid tumors | The response outcome in patient will be determined | continuous |
Status | Clinical Trial | Phase | |
---|---|---|---|
Active, not recruiting |
NCT00750841 -
Study of the Effect of Rifampicin on the Pharmacokinetics (PK) of Multiple Doses of Cediranib in Patients With Solid Tumours
|
Phase 1 | |
Withdrawn |
NCT05419817 -
Pembrolizumab With Sitravatinib in Recurrent Endometrial Cancer and Other Solid Tumors With Deficient Mismatch Repair System
|
Phase 2 | |
Completed |
NCT02828930 -
A Study to Determine the Excretion Balance, Pharmacokinetics, Metabolism and Absolute Oral Bioavailability of a Single Oral Dose of [14C]-Labeled Idasanutlin and an Intravenous Tracer Dose of [13C]-Labeled Idasanutlin in a Single Cohort of Participants With Solid Tumors (Malignancies)
|
Phase 1 | |
Completed |
NCT01197170 -
Hormone Receptor Positive Disease Across Solid Tumor Types: A Phase I Study of Single-Agent Hormone Blockade and Combination Approaches With Targeted Agents to Provide Synergy and Overcome Resistance
|
Phase 1 | |
Terminated |
NCT03225105 -
M3541 in Combination With Radiotherapy in Solid Tumors
|
Phase 1 | |
Completed |
NCT03258515 -
A Study to Investigate the Effect of Single Dose of AZD6094 (600 mg) on Cardiac Repolarization in Healthy Volunteers
|
Phase 1 | |
Completed |
NCT01497925 -
Ph 1 Trial of ADI-PEG 20 Plus Docetaxel in Solid Tumors With Emphasis on Prostate Cancer and Non-Small Cell Lung Cancer
|
Phase 1 | |
Completed |
NCT01878890 -
Phase I Dose Escalation Trial of Efavirenz in Solid Tumours or Non-Hodgkin Lymphoma in Therapeutic Failure.
|
Phase 1 | |
Active, not recruiting |
NCT05059522 -
Continued Access Study for Participants Deriving Benefit in Pfizer-Sponsored Avelumab Parent Studies That Are Closing
|
Phase 3 | |
Active, not recruiting |
NCT03634982 -
Dose Escalation of RMC-4630 Monotherapy in Relapsed/Refractory Solid Tumors
|
Phase 1 | |
Recruiting |
NCT04685226 -
A Phase I/II Clinical Trial of ICP-723 in the Treatment of Advanced Solid Tumors
|
Phase 1/Phase 2 | |
Recruiting |
NCT03175224 -
APL-101 Study of Subjects With NSCLC With c-Met EXON 14 Skip Mutations and c-Met Dysregulation Advanced Solid Tumors
|
Phase 2 | |
Recruiting |
NCT06036121 -
A Study of ADRX-0706 in Select Advanced Solid Tumors
|
Phase 1 | |
Active, not recruiting |
NCT03258151 -
Association of Genetic Polymorphisms With Docetaxel-based Chemotherapy Toxicities in Chinese Solid Tumor Patients
|
||
Completed |
NCT01528046 -
Metformin in Children With Relapsed or Refractory Solid Tumors
|
Phase 1 | |
Recruiting |
NCT05325866 -
A Study Evaluating Bemarituzumab in Solid Tumors With Fibroblast Growth Factor Receptor 2b (FGFR2b) Overexpression
|
Phase 1/Phase 2 | |
Recruiting |
NCT04557449 -
Study to Test the Safety and Tolerability of PF-07220060 in Participants With Advance Solid Tumors
|
Phase 1/Phase 2 | |
Terminated |
NCT02890368 -
Trial of Intratumoral Injections of TTI-621 in Subjects With Relapsed and Refractory Solid Tumors and Mycosis Fungoides
|
Phase 1 | |
Completed |
NCT02759640 -
A Phase I Trial of HS-10241 in Solid Tumors
|
Phase 1 | |
Withdrawn |
NCT01940601 -
Pharmacodynamics, Pharmacokinetics, Efficacy and Safety of Balugrastim in Pediatric Patients With Solid Tumors
|
Phase 2 |