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Antibodies

Antibodies, Monoclonal

Immunoglobulins

Antibodies, Bispecific

Immunologic Factors

The dose levels of OMP-305B83 will be 0.5, 1.0, 2.5, 5 and 10 mg/kg administered IV once every 3 weeks.

OMP-305B83

David Smith, MD,FACP

This is an open-label Phase 1 dose escalation and expansion study of OMP-305B83 in subjects with previously treated solid tumors. Study includes a dose escalation phase and expansion phase. Subjects will be assessed for safety, immunogenicity, pharmacokinetics, biomarkers, and efficacy.

A Phase 1 Study of OMP-305B83 in Subjects With Solid Tumors

A Phase 1 Dose Escalation and Expansion Study of OMP-305B83 in Subjects With Solid Tumors

Area under the plasma concentration-time curve, measurement of renal clearance from the body, volume of distribution, apparent half life of antibody

OncoMed Pharmaceuticals, Inc.

Micronutrients

Antineoplastic Agents

Leucovorin

Fluorouracil

Oxaliplatin

Palbociclib

Antimetabolites

Immunosuppressive Agents

Protein Kinase Inhibitors

Enzyme Inhibitors

Stage 1:

PD-0332991 daily Days 1-7 in escalating doses 5-FU 400 mg/m2 Day 8 Leucovorin 400 mg/M2 Day 8 5-FU continuous Infusion over 46 hours, 2400 mg/M2 Days 8-10

Stage 2: 3 cohorts of subjects each will be treated with the dose of PD-0332991 determined to be the recommended Phase 2 dose in Stage 1 of the study with 5-FU at the doses above but on different schedules:

Cohort 1: 5-FU bolus on Day 7 and infusion Days 7-9 Cohort 2: 5-FU bolus Day 9 and infusion Days 9-11 Cohort 3: 5-FU bolus Day 1 and infusion Days 1-3

In Stage 3, PD-0332991 and 5-FU will be given at the doses and schedule determined in Stages 1 and 2 of this study with the addition of oxaliplatin 85 mg/m2 given on the same day as the 5-FU bolus.

PD-0332991

5-FU

Michael Pishvaian, MD PhD

This study is for patients with advanced solid tumor malignancies (cancer that has spread to other parts of the body).

The purpose of this study is to test the safety and effectiveness of a new combination of drugs, PD-0332991 and 5-Fluorouracil and Oxaliplatin for patients with advanced solid tumor malignancies . PD-0332991 stops cells from dividing by blocking an enzyme called cyclin-dependent kinase (CDK), which cancer cells need to grow and divide. By inhibiting this enzyme, PD-0332991 prevent cancer cells from growing and dividing, while the 5-Fluorouracil and Oxaliplatin damage the cells, hopefully increasing the killing of cancer cells, thus decreasing the tumors in the body.

PD-0332991 is an investigational or experimental anti-cancer agent that has not yet been approved by the Food and Drug Administration for use in colorectal cancer. It is given as a pill which is taken once a day for one week followed by one week off. 5-Fluorouracil and Oxaliplatin are administered as an infusion into a vein once every 2 weeks and are approved for and used as chemotherapy for several cancers.

PD-0332991, 5-FU, and Oxaliplatin for Advanced Solid Tumor Malignancies

A Phase I Study of the CDK4/6 Inhibitor PD-0332991, 5-Fluorouracil, and Oxaliplatin in Patients With Advanced Solid Tumor Malignancies

The dose and schedule of PD-0332991 to be used in combination with 5-FU

evaluation of the effects of schedule of therapy on pharmacodynamic measures of PD-0332991 activity

Response rate as determined by RECIST 1.1

Stable disease after four cycles + partial response + complete response

Determination of the effects of 5-FU on pharmacokinetics of PD-0332991

Pfizer

Georgetown University

Amino Acids

Azacitidine

Erlotinib Hydrochloride

Tyrosine Kinase Inhibitors

Tyrosine

Erlotinib 150mg/day PO Day 1-28 and Vidaza 100mg/m2/day SQ Day 1-4 and 15-18

Erlotinib 200 mg/day PO Day 1-28 and Vidaza 75 mg/m2/day SQ 1-4 and 15-18

Erlotinib 150 mg/day PO Day 1-28 and Vidaza 75 mg/m2/day IV Day 1-3 and 15-17

Erlotinib 150 mg/day PO Day 1-28 and Vidaza 75 mg/m2/day IV Day 1-2 and 15-16

Erlotinib 150 mg/day PO Day 1-28 and Vidaza 75 mg/m2/day IV Day 1 and 15

Erlotinib 150 mg PO daily, days 1-8, and 15-22 5-Azacytidine 75 mg/m2/day, IV days 1 and 15

5-azacytidine, erlotinib

Patients enrolled to 1 of 5 cohorts, with varying drug doses and dose scheduling.

Erlotinib PO and Vidaza IV

Julie E Bauman, M.D.

PRIMARY OBJECTIVES:

I. To document the toxicities, and reversibility of toxicities, of this regimen of 5-azacytidine (azacitidine) and erlotinib (erlotinib hydrochloride).

SECONDARY OBJECTIVES:

I. To determine any potential anti-tumor effects, as determined by the objective tumor response (complete and partial responses), clinical benefit (complete and partial responses, and clinical benefit), the time to tumor response, the time to tumor progression, and the overall survival.

OUTLINE: This is a dose-escalation study.

Patients receive azacitidine intravenously (IV) over 10-40 minutes or subcutaneously (SC) on days 1 and 15, days 1-2 and 15-16, days 1-3 and 15-17, or days 1-4 and 15-18. Patients also receive erlotinib hydrochloride orally (PO) daily on days 1-21. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.

After completion of study treatment, patients are followed for 28 days and then every 3 months for 5 years.

A Phase 1 Protocol of 5-Azacytidine and Erlotinib in Advanced Solid Tumor Malignancies

New Mexico Cancer Care Alliance

Dermatologic Agents

Coal Tar

* Patients will receive single agent ATI-2231 at assigned dose levels (n=3-6 per dose level). Starting dose of 20 mg by mouth twice per day.
* Each cycle is 21 days

ATI-2231

Cynthia X Ma, M.D., Ph.D.

The purpose of this first-in-human study is to test ATI-2231 in advanced solid tumor malignancies with the goal of establishing the recommended Phase II dose of ATI-2231.

ATI-2231 in Advanced Solid Tumor Malignancies

A Phase Ia Trial of ATI-2231 in Advanced Solid Tumor Malignancies

Individual patient data may be shared upon request with other non-commercial researchers and the request will be reviewed by the study team after the publication.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
A Phase 1 Study of OMP-305B83 in Subjects With Solid Tumors	NCT02298387	Advanced Solid ...	OMP-305B83	21 Years -	Mereo BioPharma
PD-0332991, 5-FU, and Oxaliplatin for Advanced Solid Tumor Malignancies	NCT01522989	Advanced Solid ...	PD-0332991 5-FU Oxaliplatin	18 Years -	Georgetown University
PD-0332991, 5-FU, and Oxaliplatin for Advanced Solid Tumor Malignancies	NCT01522989	Advanced Solid ...	PD-0332991 5-FU Oxaliplatin	18 Years -	Georgetown University
A Phase 1 Protocol of 5-Azacytidine and Erlotinib in Advanced Solid Tumor Malignancies	NCT00996515	Advanced Solid ...	5-azacytidine, ... Erlotinib PO an...	19 Years -	New Mexico Cancer Care Alliance
ATI-2231 in Advanced Solid Tumor Malignancies	NCT05791474	Advanced Solid ... Advanced Solid ...	ATI-2231	18 Years -	Washington University School of Medicine

Spots Global Cancer Trial Database for advanced solid tumor malignancies