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- || OBI-888 / OBI Pharma
P1/2 data, Journal, Metastases: Phase I-II study of OBI-888, a humanized monoclonal IgG1 antibody against the tumor-associated carbohydrate antigen Globo H, in patients with advanced solid tumors. (Pubmed Central) - Nov 18, 2024
Prolonged SD was noted in three patients. ADCC was induced after each OBI-888 treatment.
- adagloxad simolenin (OBI 822) / OBI Pharma, OBI-888 / OBI Pharma, OBI-833 / OBI Pharma
Globo H-targeted CAR T cell cancer immunotherapy (Section 23; Poster Board #4) - Mar 14, 2023 - Abstract #AACR2023AACR_6268;
Clinical studies with the Globo H vaccines (OBI-822 and OBI-833) and the humanized anti-Globo H antibody (OBI-888) demonstrating an excellent safety profile. In conclusion, our in vitro and in vivo pharmacology and preliminary toxicology studies support clinical development of Globo H CAR T immunotherapy for patients with cancer.
- || OBI-999 / OBI Pharma
P1 data, Journal, Metastases: First-in-Human Study of OBI-999, a Globo H-Targeting Antibody-Drug Conjugate, in Patients With Advanced Solid Tumors. (Pubmed Central) - Jan 27, 2023
P1/2
The recommended phase II dose was determined to be 1.2 mg/kg once every 3 weeks. A phase II cohort-expansion study is now enrolling patients with pancreatic, colorectal, and other cancers expressing high levels of Globo H.
- | OBI-888 / OBI Pharma
Enrollment change, Trial completion date, Trial termination, Trial primary completion date, Metastases: This Study is to Evaluate Safe and Effective Treatment Dose of OBI-888 in Patients With Locally Advanced or Metastatic Solid Tumors. (clinicaltrials.gov) - Jul 8, 2022
P1/2, N=54, Terminated, Sponsor: OBI Pharma, Inc
A phase II cohort-expansion study is now enrolling patients with pancreatic, colorectal, and other cancers expressing high levels of Globo H. N=168 --> 54 | Trial completion date: Dec 2022 --> Apr 2022 | Active, not recruiting --> Terminated | Trial primary completion date: Nov 2022 --> Apr 2022; OBI-888 no longer fulfills our goal of developing cost-effective therapies for cancer patients
- || OBI-888 / OBI Pharma
Enrollment closed, Metastases: This Study is to Evaluate Safe and Effective Treatment Dose of OBI-888 in Patients With Locally Advanced or Metastatic Solid Tumors. (clinicaltrials.gov) - Nov 3, 2021
P1/2, N=168, Active, not recruiting, Sponsor: OBI Pharma, Inc
N=168 --> 54 | Trial completion date: Dec 2022 --> Apr 2022 | Active, not recruiting --> Terminated | Trial primary completion date: Nov 2022 --> Apr 2022; OBI-888 no longer fulfills our goal of developing cost-effective therapies for cancer patients Recruiting --> Active, not recruiting
- || OBI-888 / OBI Pharma
Trial completion date, Trial primary completion date, Metastases: This Study is to Evaluate Safe and Effective Treatment Dose of OBI-888 in Patients With Locally Advanced or Metastatic Solid Tumors. (clinicaltrials.gov) - Aug 8, 2020
P1/2, N=168, Recruiting, Sponsor: OBI Pharma, Inc
Recruiting --> Active, not recruiting Trial completion date: Jun 2021 --> Dec 2022 | Trial primary completion date: May 2021 --> Nov 2022
- OBI-888 / OBI Pharma
The prevalence of Globo H in different tumor types: Breast, pancreatic, lung, gastric, colorectal, liver, and esophageal cancers (Virtual Meeting II: E-Posters) - May 16, 2020 - Abstract #AACRII2020AACR-II_1785;
P1/2
Furthermore, the presence of GH-positive immune cells in the intra- or peri-tumor region lends support to the proposed mechanism of cancerous cells shedding GH-ceramide to suppress normal immune functions. The heterogeneous expression of GH among different molecular subtypes may provide a biomarker in the selection of patients for GH-directed therapies.
- | OBI-888 / OBI Pharma
Enrollment change, Metastases: This Study is to Evaluate Safe and Effective Treatment Dose of OBI-888 in Patients With Locally Advanced or Metastatic Solid Tumors. (clinicaltrials.gov) - Sep 5, 2019
P1/2, N=168, Recruiting, Sponsor: OBI Pharma, Inc
The heterogeneous expression of GH among different molecular subtypes may provide a biomarker in the selection of patients for GH-directed therapies. N=58 --> 168
- | OBI-888 / OBI Pharma
Phase classification, Metastases: This Study is to Evaluate Safe and Effective Treatment Dose of OBI-888 in Patients With Locally Advanced or Metastatic Solid Tumors. (clinicaltrials.gov) - Jul 5, 2019
P1/2, N=58, Recruiting, Sponsor: OBI Pharma, Inc
N=58 --> 168 Phase classification: P1 --> P1/2
- ||| OBI-888 / OBI Pharma
New P1 trial, Metastases: This Study is to Evaluate Safe and Effective Treatment Dose of OBI-888 in Patients With Locally Advanced or Metastatic Solid Tumors. (clinicaltrials.gov) - Jul 15, 2018
P1, N=58, Recruiting, Sponsor: OBI Pharma, Inc