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0.36, 0.54, and 0.72 mg/kg of nimesulide equivalents of CA102N on Days 1 and 15 of a 28-day cycle

0.36, 0.54, and 0.72 mg/kg of nimesulide equivalents of CA102N on Days 1 and 15 in combination with 35 mg/m2/dose of LONSURF orally twice daily on Days 1 through 5 and Days 8 through 12 of each 28-day cycle

The preliminary RP2D of CA102N on Days 1 and 15 in combination with 35 mg/m2/dose of LONSURF orally twice daily on Days 1 through 5 and Days 8 through 12 of each 28-day cycle

CA102N is a covalently bound conjugate of the biological polymer sodium hyaluronate (NaHA) and nimesulide (Nim).

CA102N

LONSURF is a cytotoxic combination treatment of 2 new drugs: trifluridine, a thymidine-based nucleoside analog, and tipiracil, an inhibitor of thymidine phosphorylase.

LONSURF

Shubham Pant, MD

Study HS-CA102N-101 is a phase 1, two part (dose escalation, dose expansion), multicenter, non-randomized, open-label, multiple dose, first-in-human study of CA102N monotherapy and of CA102N combined with trifluridine/tipiracil (LONSURF) in subjects with advanced solid tumors.

CA102N will be evaluated in subjects with locally advanced or metastatic solid tumours for which no effective therapy is available in Part 1 (dose escalation) and in subjects with relapsed or refractory locally advanced or metastatic colorectal cancer (mCRC) after prior oxaliplatin and irinotecan-based chemotherapy in Part 2 (dose expansion).

Study HS-CA102N-101 is a phase 1, two part (dose escalation, dose expansion), multicenter, non-randomized, open-label, multiple dose, first-in-human study of CA102N monotherapy and of CA102N combined with trifluridine/tipiracil (LONSURF) in subjects with advanced solid tumors.

Part 1 (dose escalation) will determine the safety and tolerability of three dose levels of CA102N as monotherapy and the safety, tolerability and preliminary recommended phase 2 dose (RP2D) of CA102N in combination with trifluridine/tipiracil (LONSURF) in patients with locally advanced or metastatic solid tumors.

Part 2 (dose expansion) will further investigate the safety and tolerability of the combination of CA102N and trifluridine/tipiracil (LONSURF) at the preliminary RP2D in patients with locally advanced or metastatic colorectal cancer that has relapsed after or is refractory to oxaliplatin and irinotecan-based chemotherapy, an anti-vascular endothelial growth factor (VEGF) biological therapy, and if RAS wild-type metastatic colorectal cancer, an anti-epidermal growth factor receptor (EGFR) therapy..

Preliminary efficacy will be evaluated in Parts 1 and 2 of the study as an exploratory endpoint.

Part 1 (dose escalation) of the study will use a conventional 3+3 design (3 subjects per dose cohort, with the potential to add an additional 3 subjects if dose limiting toxicity \[DLT\] is observed at the same dose level at which the toxicity occurred). Enrollment will occur in 2 groups, CA102N monotherapy (Group A) and CA102N combination therapy (Group B).

Subjects will be enrolled in Group A first. Once enrollment in Group A has been completed, subsequent subjects will be enrolled in Group B.

In Part 2 of the study, the safety and tolerability of the preliminary RP2D of CA102N combined with trifluridine/tipiracil (LONSURF) will be further evaluated in up to 12 additional subjects with relapsed or refractory locally advanced or metastatic colorectal cancer who have previously received oxaliplatin and irinotecan-based chemotherapy, an anti-VEGF biological therapy, and if RAS wild-type, an anti-EGFR therapy.

First-in-human Study of CA102N Monotherapy and CA102N Combined With Trifluridine/Tipiracil (LONSURF) in Subjects With Advanced Solid Tumors

Phase 1,Two-part (Dose Escalation, Dose Expansion), Multicenter,Non-randomized,Open-label, Multiple Dose, First-in-human Study of CA102N Monotherapy and of CA102N Combined With Trifluridine/Tipiracil (LONSURF) in Subjects With Advanced Solid Tumors

The exploratory endpoint of the study is to evaluate objective tumor response to CA102N monotherapy and to CA102N in combination with trifluridine/tipiracil (LONSURF) in subjects with locally advanced or metastatic solid tumors and in subjects with locally advanced or metastatic colorectal cancer. The data of tumor response will be collected and evaluated using RECIST version 1.1.

To determine the systemic alteration of COX-2 metabolites affected by CA102N by analyzing urinary COX-2 metabolites, such as PGEM, PGIM and TXBM, using LC-MS/MS.

The primary endpoint for the study is the safety and tolerability of CA102N monotherapy and CA102N combined with trifluridine/tipiracil (LONSURF) as determined according to the NCI-CTCAE version 5.0.

The secondary endpoint of the study is to measure serum concentration of CA102N (ng/mL).

Holy Stone Healthcare Co., Ltd

This study is an individual patient expanded access protocol that the subject enrolled had completed the combination treatment of CA102N plus Lonsurf for at least 12 cycles.

In the individual patient expanded access, the subject who was enrolled in Phase 1 trial (Study Number: HS-CA102N-101) Part 2 (dose expansion) and had completed at least 12 treatment cycles with CA102N combined with trifluridine /tipiracil (LONSURF) will be provided access to treatment with CA102N (0.72 mg/kg Nimesulide Equivalent of CA102N).

Individual Patient Expanded Access to CA102N

Expanded Access to CA102N in One Patient Who Completed at Least 12 Cycles of Combination Therapy of CA102N Plus Lonsurf in Clinical Study Number of HS-CA102N-101

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
First-in-human Study of CA102N Monotherapy and CA102N Combined With Trifluridine/Tipiracil (LONSURF) in Subjects With Advanced Solid Tumors	NCT03616574	Advanced or Met... Advanced or Met...	CA102N LONSURF	18 Years -	Holy Stone Healthcare Co., Ltd
First-in-human Study of CA102N Monotherapy and CA102N Combined With Trifluridine/Tipiracil (LONSURF) in Subjects With Advanced Solid Tumors	NCT03616574	Advanced or Met... Advanced or Met...	CA102N LONSURF	18 Years -	Holy Stone Healthcare Co., Ltd
Individual Patient Expanded Access to CA102N	NCT05274204	Advanced or Met...	CA102N	-	Holy Stone Healthcare Co., Ltd
Individual Patient Expanded Access to CA102N	NCT05274204	Advanced or Met...	CA102N	-	Holy Stone Healthcare Co., Ltd
Individual Patient Expanded Access to CA102N	NCT05274204	Advanced or Met...	CA102N	-	Holy Stone Healthcare Co., Ltd
Individual Patient Expanded Access to CA102N	NCT05274204	Advanced or Met...	CA102N	-	Holy Stone Healthcare Co., Ltd

Spots Global Cancer Trial Database for advanced or metastatic colorectal cancer (mcrc)