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CA102N for Colorectal Cancer

Phase 1
Waitlist Available
Led By Shubham Pant, MD
Research Sponsored by Holy Stone Healthcare Co., Ltd
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up serum sampling timepoints: predose, 0.5,1, 2, 4, 8, 12, 24, 48, and 72 hours postdose ca102n on days 1 and 15 at cycle 1 (each cycle is 28 days).
Awards & highlights

Study Summary

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

Eligible Conditions
  • Colorectal Cancer
  • Solid Tumors

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~serum sampling timepoints: predose, 0.5,1, 2, 4, 8, 12, 24, 48, and 72 hours postdose ca102n on days 1 and 15 at cycle 1 (each cycle is 28 days).
This trial's timeline: 3 weeks for screening, Varies for treatment, and serum sampling timepoints: predose, 0.5,1, 2, 4, 8, 12, 24, 48, and 72 hours postdose ca102n on days 1 and 15 at cycle 1 (each cycle is 28 days). for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Number of subjects with treatment-related adverse events as assessed by NCI-CTCAE v5.0
Secondary outcome measures
Serum concentration of CA102N
Other outcome measures
Analysis of urinary COX-2 metabolites by LC-MS/MS
Tumor response according to RECIST v1.1

Side effects data

From 2023 Phase 3 trial • 492 Patients • NCT04737187
62%
Neutropenia
37%
Nausea
28%
Anaemia
24%
Asthenia
22%
Fatigue
21%
Diarrhoea
20%
Decreased appetite
18%
Vomiting
17%
Thrombocytopenia
14%
Neutrophil count decreased
11%
Constipation
11%
Stomatitis
11%
Abdominal pain
10%
Hypertension
9%
Abdominal pain upper
9%
Platelet count decreased
9%
Aspartate aminotransferase increased
9%
Alanine aminotransferase increased
8%
Weight decreased
8%
Headache
7%
Leukopenia
7%
Arthralgia
7%
Back pain
6%
Proteinuria
5%
Blood bilirubin increased
5%
Pyrexia
3%
Intestinal obstruction
2%
Malignant neoplasm progression
2%
COVID-19
1%
Hyperbilirubinaemia
1%
Acute kidney injury
1%
Biliary dilatation
1%
Large intestinal obstruction
1%
Stoma site haemorrhage
1%
Septic shock
1%
Metastases to meninges
1%
Jaundice
1%
Bile duct stenosis
1%
Cholangitis
1%
Jaundice cholestatic
100%
80%
60%
40%
20%
0%
Study treatment Arm
Trifluridine/Tipiracil + Bevacizumab
Trifluridine/Tipiracil

Trial Design

3Treatment groups
Experimental Treatment
Group I: Dose Expansion - CA102N plus LONSURFExperimental Treatment2 Interventions
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
Group II: Dose Escalation - CA102N plus LONSURFExperimental Treatment2 Interventions
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
Group III: Dose Escalation - CA102N MonotherapyExperimental Treatment1 Intervention
0.36, 0.54, and 0.72 mg/kg of nimesulide equivalents of CA102N on Days 1 and 15 of a 28-day cycle
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
LONSURF
2019
Completed Phase 1
~40
CA102N
2019
Completed Phase 1
~40

Find a Location

Who is running the clinical trial?

Holy Stone Healthcare Co., LtdLead Sponsor
4 Previous Clinical Trials
181 Total Patients Enrolled
Shubham Pant, MDPrincipal InvestigatorThe University of Texas MD Anderson Cancer Center
4 Previous Clinical Trials
178 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Recent research and studies
clinicaltrials.govStudy
First-in-human Study of CA102N Monotherapy and CA102N Combined With Trifluridine/Tipiracil (LONSURF) in Subjects With Advanced Solid Tumors
2019. "First-in-human Study of CA102N Monotherapy and CA102N Combined With Trifluridine/Tipiracil (LONSURF) in Subjects With Advanced Solid Tumors". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03616574.
~6 spots leftby Apr 2025
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