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- ||| misitatug blivedotin (RC88) / Rongchang Pharma
Enrollment open, Monotherapy: RC88 in Platinum-Resistant Recurrent Epithelial Ovarian Cancer, Fallopian Tube Cancer, and Primary Peritoneal Cancer (clinicaltrials.gov) - Aug 28, 2024
P2, N=88, Recruiting, Sponsor: RemeGen Co., Ltd.
Not yet recruiting --> Recruiting
- misitatug blivedotin (RC88) / Rongchang Pharma
The efficacy and safety of RC88 in patients with ovarian cancer, non-squamous-non-small-cell lung-carcinoma and cervical cancer: Results from a first-in-human phase 1/2 study. (Hall A; Poster Bd #: 422) - Apr 24, 2024 - Abstract #ASCO2024ASCO_1865;
P1/2
Thirty-three (55%) had prior bevacizumab, and 29 (48.3%) had prior PARPi. RC88 demonstrated tolerable safety and encouraging preliminary efficacy in MSLN-expressing solid tumors, warranting further investigations.
- || misitatug blivedotin (RC88) / Rongchang Pharma
Trial completion date, Trial primary completion date, Metastases: A Phase I /IIa Study of RC88-ADC in Subjects With Advanced Malignant Solid Tumors (clinicaltrials.gov) - Feb 20, 2024
P1/2, N=200, Recruiting, Sponsor: RemeGen Co., Ltd.
RC88 demonstrated tolerable safety and encouraging preliminary efficacy in MSLN-expressing solid tumors, warranting further investigations. Trial completion date: May 2024 --> Sep 2025 | Trial primary completion date: Dec 2023 --> Sep 2024
- ||| misitatug blivedotin (RC88) / Rongchang Pharma
Enrollment change, Metastases: A Phase I /IIa Study of RC88-ADC in Subjects With Advanced Malignant Solid Tumors (clinicaltrials.gov) - Dec 27, 2023
P1/2, N=200, Recruiting, Sponsor: RemeGen Co., Ltd.
Trial completion date: May 2024 --> Sep 2025 | Trial primary completion date: Dec 2023 --> Sep 2024 N=51 --> 200
- ||| misitatug blivedotin (RC88) / Rongchang Pharma
Enrollment open, Trial initiation date, Metastases: A Study of RC88 Combined With Sintilimab for Advanced Solid Tumours (clinicaltrials.gov) - Dec 19, 2023
P1/2, N=82, Recruiting, Sponsor: RemeGen Co., Ltd.
N=51 --> 200 Not yet recruiting --> Recruiting | Initiation date: Apr 2023 --> Jul 2023
- || misitatug blivedotin (RC88) / Rongchang Pharma
Trial completion date, Trial primary completion date, Metastases: A Study to Assess the Safety and Tolerability of RC88 for Patients With Advanced Solid Tumours (clinicaltrials.gov) - Dec 18, 2023
P1, N=81, Recruiting, Sponsor: RemeGen Co., Ltd.
Not yet recruiting --> Recruiting | Initiation date: Apr 2023 --> Jul 2023 Trial completion date: Mar 2024 --> Dec 2024 | Trial primary completion date: Dec 2023 --> Jun 2024
- |||| misitatug blivedotin (RC88) / Rongchang Pharma
New P2 trial, Monotherapy: RC88 in Platinum-Resistant Recurrent Epithelial Ovarian Cancer, Fallopian Tube Cancer, and Primary Peritoneal Cancer (clinicaltrials.gov) - Dec 14, 2023
P2, N=88, Not yet recruiting, Sponsor: RemeGen Co., Ltd.
- || RC88 / Rongchang Pharma
PK/PD data, Preclinical, Journal: Translation of the efficacy of antibody-drug conjugates from preclinical to clinical using a semimechanistic PK/PD model: A case study with RC88. (Pubmed Central) - Jul 14, 2023
TSC from mice and predicted human PK were integrated to predict human efficacy dose. Results showed that 2 cell lines were sensitive to drugs, and the predicted efficacy dose was between 0.82 and 1.96?mg/kg q1w.
- |||| misitatug blivedotin (RC88) / Rongchang Pharma
New P1/2 trial, Metastases: A Study of RC88 Combined With Sintilimab for Advanced Solid Tumours (clinicaltrials.gov) - Apr 7, 2023
P1/2, N=82, Not yet recruiting, Sponsor: RemeGen Co., Ltd.
- ||| misitatug blivedotin (RC88) / Rongchang Pharma
New P1 trial, Metastases: A Study to Assess the Safety and Tolerability of RC88 for Patients With Advanced Solid Tumours (clinicaltrials.gov) - Aug 19, 2022
P1, N=81, Recruiting, Sponsor: RemeGen Co., Ltd.
- ||| misitatug blivedotin (RC88) / Rongchang Pharma
Phase classification, Enrollment change, Trial completion date, Trial primary completion date, Metastases: A Phase I /IIa Study of RC88-ADC in Subjects With Advanced Malignant Solid Tumors (clinicaltrials.gov) - Apr 19, 2022
P1/2, N=51, Recruiting, Sponsor: RemeGen Co., Ltd.
Results showed that 2 cell lines were sensitive to drugs, and the predicted efficacy dose was between 0.82 and 1.96?mg/kg q1w. Phase classification: P1 --> P1/2 | N=31 --> 51 | Trial completion date: May 2022 --> May 2024 | Trial primary completion date: Dec 2021 --> Dec 2023
- || misitatug blivedotin (RC88) / Rongchang Pharma
Enrollment open, Metastases: A Phase I /IIa Study of RC88-ADC in Subjects With Advanced Malignant Solid Tumors (clinicaltrials.gov) - Jun 11, 2020
P1, N=31, Recruiting, Sponsor: RemeGen
Phase classification: P1 --> P1/2 | N=31 --> 51 | Trial completion date: May 2022 --> May 2024 | Trial primary completion date: Dec 2021 --> Dec 2023 Not yet recruiting --> Recruiting
- || misitatug blivedotin (RC88) / Rongchang Pharma
New P1 trial, Metastases: A Phase I /IIa Study of RC88-ADC in Subjects With Advanced Malignant Solid Tumors (clinicaltrials.gov) - Nov 24, 2019
P1, N=31, Not yet recruiting, Sponsor: RemeGen