Advanced Solid TumorsPhase 1NCT03113188
CBP501, Cisplatin and Nivolumab in Advanced Refractory Tumors
A Phase 1 study testing CBP501 in people with Advanced Solid Tumors, run by CanBas Co. Ltd. at 3 sites in United States.
Trial summary
This is a multicenter, open-label, phase 1b study of CBP501/cisplatin/nivolumab combination administered once every 21 days to patients with advanced solid tumors. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Advanced Solid Tumors
- What is being tested?
- CBP501
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 47 participants
- Where
- 3 sitesUnited States
- Study dates
- 25 Oct 2017to 15 Feb 2021
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Signed informed consent obtained prior to initiation of any study-specific procedures and treatment;
- Previously treated, pathologically confirmed, locally advanced or metastatic solid tumors with measurable disease for which cisplatin is a reasonable treatment option, including, but not limited to, non-small cell lung, mesothelioma, head \& neck, ovarian, endometrial, breast, bladder, kidney, esophageal, gastric, colon, liver, gallbladder, cholangiocarcinoma, pancreas, soft tissue sarcoma, and osteosarcoma (for the expansion cohorts, only metastatic exocrine pancreatic cancer and microsatellite stable colorectal cancer are allowed). There is no limit on the number of prior lines of chemotherapy (including prior cisplatin), chemoradiotherapy, radiotherapy or investigational agents the patient can have received in order to be eligible, as long as cisplatin is a reasonable treatment option and all eligibility criteria are met, with the exception that a patient must not have received more than two prior lines incorporating anti-PD-1, anti-PD-L1, or anti-CTLA-4 immune checkpoint blockade.
- Patients who have received prior anti-PD-1, anti-PD-L1, or anti-CTLA-4 immune checkpoint blockade therapy must have tolerated therapy with no evidence of grade 4 toxicity or an immune-related event (any grade) that required treatment discontinuation. Patients who experienced an endocrine related dysfunction are eligible, provided they are on stable hormone replacement therapy;
- Male or female patients aged ≥ 18 years at time of informed consent;
- ECOG Performance Status (PS) 0-1;
- Life expectancy > 3 months;
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- Previous anticancer treatment must be discontinued at least 3 weeks prior to the initiation of study treatment (6 weeks for mitomycin C; 6 weeks for anti-androgen therapy if discontinued prior to treatment initiation, except 8 weeks for bicalutamide);
- Adequate bone marrow reserve, cardiac, liver, renal and metabolic function:
- absolute neutrophil count (ANC) ≥ 1.5 x 109/L;
- platelet count ≥ 100 x 109/L;
- hemoglobin ≥ 9 g/dL;
- white blood cell count (WBC) ≤ upper limit of normal (ULN);
- creatinine phosphokinase isozymes CPK-MB and CPK-MM
- ≤ ULN;
- serum troponin T levels within normal limits;
- bilirubin ≤ 1.5 x ULN;
- alanine aminotransferase (ALT, SGPT) and aspartate aminotransferase (AST, SGOT) ≤ 2.5 x ULN (≤ 5 x ULN if liver metastases are present);
- INR ≤ 1.5 x ULN;
- serum creatinine ≤ ULN or creatinine clearance ≥ 60 mL/min (by Cockroft \& Gault formula or alternate calculation by 24hr urine collection);
- serum potassium NCI-CTCAE version 4.03 Grade <2;
- serum calcium NCI-CTCAE version 4.03 Grade <2;
- serum magnesium NCI-CTCAE version 4.03 Grade <2;
- Female patients of child-bearing potential must have a negative serum pregnancy test and use at least one form of contraception as approved by the investigator for 4 weeks prior to initiating study treatment and 4 months after the last dose of study drug. For the purposes of this study, child-bearing potential is defined as "all female patients unless they are post-menopausal for at least 3 years or surgically sterile";
- Male patients must use a form of barrier contraception approved by the investigator during the study and for 4 months after the last dose of study drug;
- Ability to cooperate with study treatment and follow-up.
Who cannot join
- Radiation therapy to >30% of bone marrow prior to study entry;
- Prior chemotherapy with nitrosoureas, prior mitomycin C cumulative dose ≥ 25 mg/m2, prior bone marrow transplant, or prior intensive chemotherapy with stem cell support;
- Presence of any serious concomitant systemic disorders incompatible with the study in the opinion of the investigator (e.g., uncontrolled congestive heart failure, active infection, etc.);
- Any previous history of another malignancy (other than cured basal cell or squamous cell carcinoma of the skin or cured in-situ carcinoma) within 5 years of study entry;
- Presence of any significant central nervous system (CNS) or psychiatric disorder(s) that would hamper the patient's compliance;
- Evidence of peripheral neuropathy > grade 1 by NCI-CTCAE version 4.03;
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- Treatment with any other investigational agent or participation in another clinical trial within 28 days prior to study entry;
- Pregnant or breast-feeding patients or any patient with child-bearing potential not using adequate contraception;
- Known HIV, HBV, or HCV infection (excluding cured HCV infection);
- Active CNS metastases; however, patients with CNS metastases will be eligible if they have been treated and are stable without symptoms for 4 weeks after completion of treatment, with image documentation required, and must be off steroids;
- Who require chronic systemic steroid therapy or on any other form of immunosuppressive medication;
- Has received a live-virus vaccination within 30 days of planned treatment start;
- With known risk factors for bowel perforation, i.e., history of diverticulitis, intra-abdominal abscess, intestinal obstruction, or abdominal carcinomatosis;
- Has an active autoimmune disease or a documented history of autoimmune disease;
- Has a history pneumonitis or interstitial lung disease.
Trial locations and contacts
3 sites in 1 country.
United States3 sites
Dana Farber Cancer Institute
Boston, Massachusetts, 02215
Ochsner Clinic Foundation
New Orleans, Louisiana, 70121
HonorHealth
Scottsdale, Arizona, 85258
About this study
Official title: Phase 1b Clinical Study of CBP501, Cisplatin and Nivolumab Administered Every 3 Weeks in Patients With Advanced Refractory Tumors
This is a multicenter, open-label, phase 1b study of CBP501/cisplatin/nivolumab combination administered once every 21 days to patients with advanced solid tumors.
Read the detailed description
Multicenter, open-label, phase 1b study of CBP501/cisplatin/nivolumab combination administered once every 21 days to patients with advanced solid tumors. The study will be conducted in two parts.
The first part of the study involves dose-escalation, in which successive cohorts of three patients (expanded up to six patients in the event of a dose-limiting toxicity (DLT) or safety concerns) will receive escalating doses of CBP501 and/or cisplatin until the maximum tolerated dose (MTD) is reached or RP2D defined, based on tolerability observed during the first 21 days of treatment and safety review of all available information by the Safety Monitoring Committee.
The second part of the study involves treatment of expansion cohorts of 10 evaluable patients each in pretreated metastatic exocrine pancreatic cancer and in microsatellite stable colorectal cancer to confirm the tolerability of treatment at the RP2D and evaluate preliminary evidence of anti-tumor activity in these indications.
- Conditions
- Advanced Solid Tumors
- Being tested
- CBP501
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CBP501Drug
CBP501, CDDP plus Nivolumab
| Study group | Role | What they receive |
|---|---|---|
| CBP501, CDDP, Nivolumab | Experimental | CBP501, Cisplatin and Nivolumab Administered Every 3 Weeks in Patients with Advanced Refractory Tumors Receives: Drug: CBP501 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Recommended dose
Define the recommended doses (RP2D) of CBP501, cisplatin and nivolumab when administered in combination once every 21 days in patients with previously treated advanced solid tumors
Measured: 21 days
Secondary outcomes (1)
Hint of efficacy in pretreated pancreatic and micro-satellite stable colorectal cancer patients
Overall response rate will be analyzed according to Simon optimal stage 1 design
Measured: through study completion, an average of 6 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Apr 2017
- Study start25 Oct 2017
- Primary completion15 Feb 2021
- Study completion15 Feb 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Advanced Solid TumorsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Dose finding cohort plus confirmatory expansion cohort
- Masking
- None (open label)
- Enrolment
- 47 participants (actual)
Sponsor and investigators
- Lead sponsor
- CanBas Co. Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Geoffrey I Shapiro, MD, Principal investigator, Dana-Farber Cancer Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03113188
- Sponsor's protocol ID
- CBP17-01
- Status last verified
- Oct 2020
- First submitted
- 9 Apr 2017
- Last updated
- 10 Mar 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Mine N, Yamamoto S, Kufe DW, Von Hoff DD, Kawabe T. Activation of Nrf2 pathways correlates with resistance of NSCLC cell lines to CBP501 in vitro. Mol Cancer Ther. 2014 Sep;13(9):2215-25. doi: 10.1158/1535-7163.MCT-13-0808. Epub 2014 Jul 22.
PubMed 25053821Krug LM, Wozniak AJ, Kindler HL, Feld R, Koczywas M, Morero JL, Rodriguez CP, Ross HJ, Bauman JE, Orlov SV, Ruckdeschel JC, Mita AC, Fein L, He X, Hall R, Kawabe T, Sharma S. Randomized phase II trial of pemetrexed/cisplatin with or without CBP501 in patients with advanced malignant pleural mesothelioma. Lung Cancer. 2014 Sep;85(3):429-34. doi: 10.1016/j.lungcan.2014.06.008. Epub 2014 Jul 5.
PubMed 25047675Matsumoto Y, Shindo Y, Takakusagi Y, Takakusagi K, Tsukuda S, Kusayanagi T, Sato H, Kawabe T, Sugawara F, Sakaguchi K. Screening of a library of T7 phage-displayed peptides identifies alphaC helix in 14-3-3 protein as a CBP501-binding site. Bioorg Med Chem. 2011 Dec 1;19(23):7049-56. doi: 10.1016/j.bmc.2011.10.004. Epub 2011 Oct 7.
PubMed 22032894Mine N, Yamamoto S, Saito N, Yamazaki S, Suda C, Ishigaki M, Kufe DW, Von Hoff DD, Kawabe T. CBP501-calmodulin binding contributes to sensitizing tumor cells to cisplatin and bleomycin. Mol Cancer Ther. 2011 Oct;10(10):1929-38. doi: 10.1158/1535-7163.MCT-10-1139. Epub 2011 Aug 10.
PubMed 21831962Shapiro GI, Tibes R, Gordon MS, Wong BY, Eder JP, Borad MJ, Mendelson DS, Vogelzang NJ, Bastos BR, Weiss GJ, Fernandez C, Sutherland W, Sato H, Pierceall WE, Weaver D, Slough S, Wasserman E, Kufe DW, Von Hoff D, Kawabe T, Sharma S. Phase I studies of CBP501, a G2 checkpoint abrogator, as monotherapy and in combination with cisplatin in patients with advanced solid tumors. Clin Cancer Res. 2011 May 15;17(10):3431-42. doi: 10.1158/1078-0432.CCR-10-2345. Epub 2011 Jan 10.
PubMed 21220472Sha SK, Sato T, Kobayashi H, Ishigaki M, Yamamoto S, Sato H, Takada A, Nakajyo S, Mochizuki Y, Friedman JM, Cheng FC, Okura T, Kimura R, Kufe DW, Vonhoff DD, Kawabe T. Cell cycle phenotype-based optimization of G2-abrogating peptides yields CBP501 with a unique mechanism of action at the G2 checkpoint. Mol Cancer Ther. 2007 Jan;6(1):147-53. doi: 10.1158/1535-7163.MCT-06-0371.
PubMed 17237275
Study at a glance
From the registry record, last updated by the sponsor on 10 Mar 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase 1b Clinical Study of CBP501, Cisplatin and Nivolumab Administered Every 3 Weeks in Patients With Advanced Refractory Tumors
- ClinicalTrials.gov ID
- NCT03113188
- Acronym / sponsor ID
- CBP17-01
- Conditions
- Advanced Solid Tumors
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 47 participants (actual)
- Lead sponsor
- CanBas Co. Ltd.Industry (pharma, biotech, devices)
- Study start
- 25 Oct 2017 (actual)
- Primary completion
- 15 Feb 2021 (actual)
- Study completion
- 15 Feb 2021 (actual)
- First posted
- 13 Apr 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a multicenter, open-label, phase 1b study of CBP501/cisplatin/nivolumab combination administered once every 21 days to patients with advanced solid tumors.
Detailed description
Multicenter, open-label, phase 1b study of CBP501/cisplatin/nivolumab combination administered once every 21 days to patients with advanced solid tumors. The study will be conducted in two parts.
The first part of the study involves dose-escalation, in which successive cohorts of three patients (expanded up to six patients in the event of a dose-limiting toxicity (DLT) or safety concerns) will receive escalating doses of CBP501 and/or cisplatin until the maximum tolerated dose (MTD) is reached or RP2D defined, based on tolerability observed during the first 21 days of treatment and safety review of all available information by the Safety Monitoring Committee.
The second part of the study involves treatment of expansion cohorts of 10 evaluable patients each in pretreated metastatic exocrine pancreatic cancer and in microsatellite stable colorectal cancer to confirm the tolerability of treatment at the RP2D and evaluate preliminary evidence of anti-tumor activity in these indications.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Dose finding cohort plus confirmatory expansion cohort
| Arm | Type | Receives |
|---|---|---|
| CBP501, CDDP, Nivolumab | Experimental | Drug: CBP501CBP501, Cisplatin and Nivolumab Administered Every 3 Weeks in Patients with Advanced Refractory Tumors |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (25 listed)
- Signed informed consent obtained prior to initiation of any study-specific procedures and treatment;
- Previously treated, pathologically confirmed, locally advanced or metastatic solid tumors with measurable disease for which cisplatin is a reasonable treatment option, including, but not limited to, non-small cell lung, mesothelioma, head \& neck, ovarian, endometrial, breast, bladder, kidney, esophageal, gastric, colon, liver, gallbladder, cholangiocarcinoma, pancreas, soft tissue sarcoma, and osteosarcoma (for the expansion cohorts, only metastatic exocrine pancreatic cancer and microsatellite stable colorectal cancer are allowed). There is no limit on the number of prior lines of chemotherapy (including prior cisplatin), chemoradiotherapy, radiotherapy or investigational agents the patient can have received in order to be eligible, as long as cisplatin is a reasonable treatment option and all eligibility criteria are met, with the exception that a patient must not have received more than two prior lines incorporating anti-PD-1, anti-PD-L1, or anti-CTLA-4 immune checkpoint blockade.
- Patients who have received prior anti-PD-1, anti-PD-L1, or anti-CTLA-4 immune checkpoint blockade therapy must have tolerated therapy with no evidence of grade 4 toxicity or an immune-related event (any grade) that required treatment discontinuation. Patients who experienced an endocrine related dysfunction are eligible, provided they are on stable hormone replacement therapy;
- Male or female patients aged ≥ 18 years at time of informed consent;
- ECOG Performance Status (PS) 0-1;
Key exclusion criteria (15 listed)
- Radiation therapy to >30% of bone marrow prior to study entry;
- Prior chemotherapy with nitrosoureas, prior mitomycin C cumulative dose ≥ 25 mg/m2, prior bone marrow transplant, or prior intensive chemotherapy with stem cell support;
- Presence of any serious concomitant systemic disorders incompatible with the study in the opinion of the investigator (e.g., uncontrolled congestive heart failure, active infection, etc.);
- Any previous history of another malignancy (other than cured basal cell or squamous cell carcinoma of the skin or cured in-situ carcinoma) within 5 years of study entry;
- Presence of any significant central nervous system (CNS) or psychiatric disorder(s) that would hamper the patient's compliance;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CBP501CBP501, CDDP plus Nivolumab | Drug | CBP501, CDDP, Nivolumab |
Primary outcome
Recommended dose
Time frame: 21 days
Define the recommended doses (RP2D) of CBP501, cisplatin and nivolumab when administered in combination once every 21 days in patients with previously treated advanced solid tumors
1 secondary outcome
Hint of efficacy in pretreated pancreatic and micro-satellite stable colorectal cancer patients
Time frame: through study completion, an average of 6 month
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Mar 2021.
- Background: PubMed 25053821Mine N, Yamamoto S, Kufe DW, Von Hoff DD, Kawabe T. Activation of Nrf2 pathways correlates with resistance of NSCLC cell lines to CBP501 in vitro. Mol Cancer Ther. 2014 Sep;13(9):2215-25. doi: 10.1158/1535-7163.MCT-13-0808. Epub 2014 Jul 22.
- Background: PubMed 25047675Krug LM, Wozniak AJ, Kindler HL, Feld R, Koczywas M, Morero JL, Rodriguez CP, Ross HJ, Bauman JE, Orlov SV, Ruckdeschel JC, Mita AC, Fein L, He X, Hall R, Kawabe T, Sharma S. Randomized phase II trial of pemetrexed/cisplatin with or without CBP501 in patients with advanced malignant pleural mesothelioma. Lung Cancer. 2014 Sep;85(3):429-34. doi: 10.1016/j.lungcan.2014.06.008. Epub 2014 Jul 5.
- Background: PubMed 22032894Matsumoto Y, Shindo Y, Takakusagi Y, Takakusagi K, Tsukuda S, Kusayanagi T, Sato H, Kawabe T, Sugawara F, Sakaguchi K. Screening of a library of T7 phage-displayed peptides identifies alphaC helix in 14-3-3 protein as a CBP501-binding site. Bioorg Med Chem. 2011 Dec 1;19(23):7049-56. doi: 10.1016/j.bmc.2011.10.004. Epub 2011 Oct 7.
- Background: PubMed 21831962Mine N, Yamamoto S, Saito N, Yamazaki S, Suda C, Ishigaki M, Kufe DW, Von Hoff DD, Kawabe T. CBP501-calmodulin binding contributes to sensitizing tumor cells to cisplatin and bleomycin. Mol Cancer Ther. 2011 Oct;10(10):1929-38. doi: 10.1158/1535-7163.MCT-10-1139. Epub 2011 Aug 10.
- Background: PubMed 21220472Shapiro GI, Tibes R, Gordon MS, Wong BY, Eder JP, Borad MJ, Mendelson DS, Vogelzang NJ, Bastos BR, Weiss GJ, Fernandez C, Sutherland W, Sato H, Pierceall WE, Weaver D, Slough S, Wasserman E, Kufe DW, Von Hoff D, Kawabe T, Sharma S. Phase I studies of CBP501, a G2 checkpoint abrogator, as monotherapy and in combination with cisplatin in patients with advanced solid tumors. Clin Cancer Res. 2011 May 15;17(10):3431-42. doi: 10.1158/1078-0432.CCR-10-2345. Epub 2011 Jan 10.
- Background: PubMed 17237275Sha SK, Sato T, Kobayashi H, Ishigaki M, Yamamoto S, Sato H, Takada A, Nakajyo S, Mochizuki Y, Friedman JM, Cheng FC, Okura T, Kimura R, Kufe DW, Vonhoff DD, Kawabe T. Cell cycle phenotype-based optimization of G2-abrogating peptides yields CBP501 with a unique mechanism of action at the G2 checkpoint. Mol Cancer Ther. 2007 Jan;6(1):147-53. doi: 10.1158/1535-7163.MCT-06-0371.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Geoffrey I Shapiro, MD principal investigator
Dana-Farber Cancer Institute
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing CBP501 in people with Advanced Solid Tumors, run by CanBas Co. Ltd. at 3 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 25 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 10 Mar 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Recommended dose (time frame: 21 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03113188, which also lists 6 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Mar 2021.