Clinical Trials List
Protocol NumberCVPM087A2101
NCT Number(ClinicalTrials.gov Identfier)NCT03798626
Completed
2019-04-19 - 2025-11-11
Phase I
Recruiting1
ICD-10C19
Malignant neoplasm of rectosigmoid junction
ICD-10Z51.12
Encounter for antineoplastic immunotherapy
ICD-9154.0
Malignant neoplasm of rectosigmoid junction
Phase Ib study of gevokizumab in combination with standard of care anti-cancer therapies in patients with metastatic colorectal cancer, gastroesophageal cancer and renal cell carcinoma
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Trial Applicant
NOVARTIS (TAIWAN) CO., LTD.
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Sponsor
Novartis Pharmaceuticals
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Trial scale
Multi-Regional Multi-Center
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Update
2026/02/01
Investigators and Locations
Co-Principal Investigator
- Peng-Chan Lin 無
- Jui-Hung Tsai 無
- Wu-Chou Su 無
- Po-Wen Lin 無
- Shang-Hung Chen 無
- 黃盈慈 無
The Actual Total Number of Participants Enrolled
0 Recruiting
Condition/Disease
Colorectal Cancer / Gastroesophageal Cancer / Renal Cell Carcinoma
Objectives
This study will determine the pharmacodynamically-active dose of gevokizumab and the tolerable dose and preliminary efficacy of gevokizumab in combination with the standard of care anti-cancer therapy in patients with metastatic colorectal cancer, metastatic gastroesophageal cancer and metastatic renal cell carcinoma.
Test Drug
VPM087 (Gevokizumab)
Active Ingredient
VPM087 (Gevokizumab)
Dosage Form
Solution for infusion
Dosage
60 mg/mL/vial
Endpoints
Primary Outcome Measures:
1. Part 1a (Dose finding): Change in high-sensitivity C-reactive protein (hsCRP) after first dose of gevokizumab monotherapy.
2. Part 1b (Safety run-in): Number of dose limiting toxicities (DLTs).
3. Part 1b (Safety run-in): Number of DLTs.
4. Part 2 (Expansion): Progression free survival (PFS) rate per investigator assessment using RECIST v1.1.
5. Part 2 (Expansion): Progression free survival (PFS) rate per investigator assessment using RECIST v1.1.
6. Part 2 (Expansion): Progression free survival (PFS) rate per investigator assessment using RECIST v1.1.
Secondary Outcome Measures:
1. Part 2 (Expansion): Overall response rate (ORR) per investigator assessment using RECIST v1.1.
2. Part 2 (Expansion): Duration of response (DOR) per investigator assessment using RECIST v1.1.
3. Part 2 (Expansion): Disease Control Rate (DCR) per investigator assessment using RECIST v1.1.
4. Part 2 (Expansion): Overall survival (OS).
5. Serum concentration of gevokizumab, as monotherapy and in the combination regimens.
6. Serum concentration of bevacizumab.
7. Serum concentration of ramucirumab.
8. Serum concentration of irinotecan.
9. Serum concentration of paclitaxel.
10. Serum concentration of cabozantinib.
11. Number of patients with anti-drug antibodies for gevokizumab in the combination regimens.
12. Number of patients with anti-drug antibodies for bevacizumab in the combination regimens.
13. Number of patients with anti-drug antibodies for ramucirumab in the combination regimens.
1. Part 1a (Dose finding): Change in high-sensitivity C-reactive protein (hsCRP) after first dose of gevokizumab monotherapy.
2. Part 1b (Safety run-in): Number of dose limiting toxicities (DLTs).
3. Part 1b (Safety run-in): Number of DLTs.
4. Part 2 (Expansion): Progression free survival (PFS) rate per investigator assessment using RECIST v1.1.
5. Part 2 (Expansion): Progression free survival (PFS) rate per investigator assessment using RECIST v1.1.
6. Part 2 (Expansion): Progression free survival (PFS) rate per investigator assessment using RECIST v1.1.
Secondary Outcome Measures:
1. Part 2 (Expansion): Overall response rate (ORR) per investigator assessment using RECIST v1.1.
2. Part 2 (Expansion): Duration of response (DOR) per investigator assessment using RECIST v1.1.
3. Part 2 (Expansion): Disease Control Rate (DCR) per investigator assessment using RECIST v1.1.
4. Part 2 (Expansion): Overall survival (OS).
5. Serum concentration of gevokizumab, as monotherapy and in the combination regimens.
6. Serum concentration of bevacizumab.
7. Serum concentration of ramucirumab.
8. Serum concentration of irinotecan.
9. Serum concentration of paclitaxel.
10. Serum concentration of cabozantinib.
11. Number of patients with anti-drug antibodies for gevokizumab in the combination regimens.
12. Number of patients with anti-drug antibodies for bevacizumab in the combination regimens.
13. Number of patients with anti-drug antibodies for ramucirumab in the combination regimens.
Inclution Criteria
1. Metastatic disease not amenable to potentially curative surgery and with available archival tumor tissue or fresh tumor tissue biopsy.
2. Presence of at least 1 measurable lesion assessed by CT and/or MRI according to RECIST 1.1.
For Cohort A:
- First line metastatic colorectal cancer.
For Cohort B:
- Second line metastatic colorectal cancer that has progressed on prior chemotherapy administered for metastatic disease and which must include a fluoropyrimidine and oxaliplatin.
For Cohort C:
- Second line metastatic gastroesophageal cancer that has progressed on prior line of chemotherapy administered for metastatic disease, and which must include a platinum agent and fluoropyrimidine doublet.
For Cohort D:
- Second or third line metastatic renal cell carcinoma with a clear-cell component and has received one or two lines of treatment for metastatic disease that included an anti-angiogenic agent for at least 4 weeks with radiologic progression on that treatment.
For subjects starting from Part 1a in Cohorts A and B:
1. Serum hs-CRP at screening ≥ 10 mg/L.
2. Not requiring immediate initiation of anti-cancer therapy per investigator's best judgement.
For subjects starting from Part 2 in Cohorts C and D:
- Serum hs-CRP at screening ≥ 10 mg/L.
2. Presence of at least 1 measurable lesion assessed by CT and/or MRI according to RECIST 1.1.
For Cohort A:
- First line metastatic colorectal cancer.
For Cohort B:
- Second line metastatic colorectal cancer that has progressed on prior chemotherapy administered for metastatic disease and which must include a fluoropyrimidine and oxaliplatin.
For Cohort C:
- Second line metastatic gastroesophageal cancer that has progressed on prior line of chemotherapy administered for metastatic disease, and which must include a platinum agent and fluoropyrimidine doublet.
For Cohort D:
- Second or third line metastatic renal cell carcinoma with a clear-cell component and has received one or two lines of treatment for metastatic disease that included an anti-angiogenic agent for at least 4 weeks with radiologic progression on that treatment.
For subjects starting from Part 1a in Cohorts A and B:
1. Serum hs-CRP at screening ≥ 10 mg/L.
2. Not requiring immediate initiation of anti-cancer therapy per investigator's best judgement.
For subjects starting from Part 2 in Cohorts C and D:
- Serum hs-CRP at screening ≥ 10 mg/L.
Exclusion Criteria
For All Cohorts:
1. Currently receiving any of the prohibited medications or has contraindications as outlined in the protocol.
2. Symptomatic brain metastases or brain metastases that require directed therapy (such as focal radiotherapy or surgery).
3. Suspected or proven immunocompromised state, or infections (as defined in the protocol).
4. Conditions that have a high risk of clinically significant bleeding after administration of anti-VEGF agents.
5. Clinically significant, uncontrolled or recent (within last 6 months) cardiovascular disease.
For Cohort D:
1. Concomitant medications, herbal supplements, and/or fruits and their juices that are known as strong inhibitors or inducers of CYP3A4/5, and medications that have a narrow therapeutic window and are predominantly metabolized through CYP3A4/5.
2. Impairment of GI function or GI disease that may significantly alter the absorption of cabozantinib.
1. Currently receiving any of the prohibited medications or has contraindications as outlined in the protocol.
2. Symptomatic brain metastases or brain metastases that require directed therapy (such as focal radiotherapy or surgery).
3. Suspected or proven immunocompromised state, or infections (as defined in the protocol).
4. Conditions that have a high risk of clinically significant bleeding after administration of anti-VEGF agents.
5. Clinically significant, uncontrolled or recent (within last 6 months) cardiovascular disease.
For Cohort D:
1. Concomitant medications, herbal supplements, and/or fruits and their juices that are known as strong inhibitors or inducers of CYP3A4/5, and medications that have a narrow therapeutic window and are predominantly metabolized through CYP3A4/5.
2. Impairment of GI function or GI disease that may significantly alter the absorption of cabozantinib.
The Estimated Number of Participants
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Taiwan
5 participants
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Global
167 participants
