BMS-986207 for Cancer

Phase-Based Estimates
1
Effectiveness
1
Safety
Local Institution, Kashiwa-shi, Japan
+1 More
BMS-986207 - Drug
Eligibility
18+
All Sexes
Eligible conditions
Cancer

Study Summary

This study is evaluating whether a medication may help treat solid cancers.

See full description

Eligible Conditions

  • Cancer
  • Neoplasms
  • Broad Solid Tumor

Treatment Effectiveness

Effectiveness Estimate

1 of 3

Compared to trials

Study Objectives

This trial is evaluating whether BMS-986207 will improve 10 primary outcomes and 15 secondary outcomes in patients with Cancer. Measurement will happen over the course of Up to 6 weeks.

At 24 Weeks
Progression-free survival rate (PFSR) at 24 weeks by RECIST v1.1
Progression-free survival rate (PFSR) at 24 weeks by Response Evaluation Criteria in Solid Tumors (RECIST) v1.1
At 24 weeks
Progression-free survival rate (PFSR) at 24 weeks by Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 by Investigator
Up to 15 months
Accumulation Index (AI)
Area under the concentration-time curve in one dosing interval AUC(TAU)
Average concentration over a dosing interval (Css-avg)
Effective elimination half-life that explains the degree of accumulation observed for a specific exposure measure (T-HALFeff)
Incidence of clinically significant changes in clinical laboratory results: Clinical Chemistry tests
Incidence of clinically significant changes in clinical laboratory results: Hematology tests
Incidence of clinically significant changes in clinical laboratory results: Urinalysis tests
Observed concentration at the end of a dosing interval (Ctau)
Total body clearance (CLT)
Trough observed serum concentrations (Ctrough)
Up to 27 months
Area under the serum concentration-time curve from time zero to time of last quantifiable concentration AUC(0-T)
Incidence of AEs leading to discontinuation
Incidence of Adverse Events (AEs)
Incidence of Serious Adverse Events (SAEs)
Incidence of anti-drug antibody (ADA)
Incidence of deaths
Maximum observed serum concentration (Cmax)
Number of participants with laboratory abnormalities
Time of maximum observed serum concentration (Tmax)
Up to 36 months
Median duration of response (mDOR)
Objective response rate (ORR)
Up to 6 weeks
Incidence of AEs meeting protocol-defined dose limiting toxicity (DLT) criteria

Trial Safety

Safety Estimate

1 of 3

Compared to trials

Trial Design

12 Treatment Groups

No Control Group
Part 1B: Dose Escalation Combination Therapy (BMS-986207 + nivolumab)

This trial requires 241 total participants across 12 different treatment groups

This trial involves 12 different treatments. BMS-986207 is the primary treatment being studied. Participants will be divided into 12 treatment groups. There is no placebo group. The treatments being tested are in Phase 1 & 2 and have already been tested with other people.

Part 1B: Dose Escalation Combination Therapy (BMS-986207 + nivolumab)
Part 1B: Dose Escalation Combination Therapy
Part 2C: Triplet Expansion
Part 1A: Dose Escalation Monotherapy
Drug
Part 1C: Triplet Cohort
Part 2B: Expansion Combination Therapy (BMS-986207 + nivolumab)
Part 1C: Triplet Cohort (BMS-986207 + nivolumab + ipilimumab)
Part 2B: Expansion Combination Therapy
Part 2C: Triplet Expansion (BMS-986207 + nivolumab + ipilimumab)
Part 1A: Dose Escalation Monotherapy (BMS-986207)
Drug
Part 2A: Expansion Monotherapy
Drug
Part 2A: Expansion Monotherapy (BMS-986207)
Drug
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Ipilimumab
FDA approved
Nivolumab
FDA approved

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: up to 36 months
This trial has the following approximate timeline: 3 weeks for initial screening, variable treatment timelines, and roughly up to 36 months for reporting.

Closest Location

UPMC Cancer Center - Pittsburgh, PA

Eligibility Criteria

This trial is for patients born any sex aged 18 and older. There are 3 eligibility criteria to participate in this trial as listed below.

Mark “yes” if the following statements are true for you:
Must have pre-existing or prior programmed death-ligand 1 (PD-L1) immunohistochemistry (IHC) results within 3 months of enrollment from testing of tumor tissue; PD-L1 expression must be tumor cell positive ≥ 1% for a participant to be eligible for enrollment
You have a performance status of 0 or 1. show original
Patient must have measurable disease by CT or MRI per RECIST v1.1 criteria; radiographic tumor assessment performed within 28 days before randomization. show original

Patient Q&A Section

Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What are common treatments for broad solid tumor?

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Most broad solid cancers have varying treatment strategies based on primary tumor location and stage and metastatic disease progression; however, nonsurgical treatment is commonly prescribed as an alternative to palliative care. For locally advanced non-specific disease, such as brain metastasis, surgery with either whole, gross total, or subtotal elimination of the primary tumor are commonly performed in the palliative care setting. As surgical approaches are now being used for systemic metastatic disease, surgery continues to be prescribed, regardless of the disease type.

Unverified Answer

How many people get broad solid tumor a year in the United States?

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[Appropriate chemotherapy regimen for broad solid tumors in the United States is unclear] answer: <40% of individuals with broad solid tumors receive appropriate chemotherapy for them. This requires a substantial commitment to improving and/or expanding utilization of [appropriate chemotherapy regimens for broad solid tumors] for this common and often debilitating cancer.

Unverified Answer

What is broad solid tumor?

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Solid tumors involve different types of cells (epithelial or mesenchymal) which can take part in various types of cellular proliferation and migration, and can be located on various organs (skin, breast, lung, prostate, bone, etc.) that may occur in different forms, which can grow (localized) or disseminate (dissemination) and can metastasize (dissemination).

Unverified Answer

What causes broad solid tumor?

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There is an association between cigarette smoking and solid tumor, especially in females. Other, as yet unidentified or underreported, factors may cause solid tumor in women but not in men.

Unverified Answer

Can broad solid tumor be cured?

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All main broad solid cancer components are equally metastatic and curable, suggesting that there is a uniform metastatic spread and that the different broad solid tumors with their particular features are, largely, phenotypically equivalent. No difference in the post-immunosuppressant survival time was found. However, further investigations are needed to examine the potential differences in the natural history of the various cancers. This should be addressed by following up a number of metastatic cancers before drawing the conclusions.

Unverified Answer

What are the signs of broad solid tumor?

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In a recent study, findings has found that common signs of broad solid tumors are swelling of the stomach and loss of appetite. Other signs include weight loss, fatigue and weakness. Patients are most commonly seen when they present with painless, enlarging lymph nodes.

Unverified Answer

Who should consider clinical trials for broad solid tumor?

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SCT patients with progressive disease should routinely consider clinical trials. Trial results may guide the initiation of systemic therapy to improve outcomes. The benefit of trial participation should be balanced against the risk of morbidity from systemic therapies. The use of clinical trial data to guide and optimize systemic therapies remains underutilized.

Unverified Answer

Is bms-986207 safe for people?

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Based on these data, it appears that BS-986207 at the dose and schedule given was safe and well tolerated. Additional evaluations are needed to clarify the exact rate of toxicities caused by BS-986207.

Unverified Answer

Has bms-986207 proven to be more effective than a placebo?

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Bms--987207 was well tolerated, caused no new safety risks and effectively stimulated CCRT2, thus providing a promising drug for the treatment of breast cancer. However, to overcome the drawbacks of a standard chemotherapy regimen, higher doses need to be evaluated in the clinical setting.

Unverified Answer

What are the latest developments in bms-986207 for therapeutic use?

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This work provides new insights in the binding of human receptor hPTP1, the first of the three subfamily of the PTP family of protein-tyrosine phosphatases with unknown structural and evolutionary homologies. This work provides an important addition on the structural and functional information on the PTP family of protein-tyrosine phosphatase that is currently being elucidated.

Unverified Answer

Have there been other clinical trials involving bms-986207?

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Clinical trial results of BMS-986207 were described by a large series of publications from a number of major pharmaceutical companies and by a report from the FDA. Clinical trials of a single dose of BMS-986207 have been completed by Eli Lilly and Company. BMS-986207 is a potent mTOR inhibitor in proof-of-principle studies in patients with solid tumors with positive feedback in the mTOR pathway due to mTOR mutation or amplification. BMS-986207 is currently under active investigation in a Phase I single-agent study in patients with solid tumors with tumor cells with positive feedback due to PI3K mutation/amplification. BMS-986207 also shows promising efficacy in combination studies.

Unverified Answer

How serious can broad solid tumor be?

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Most, if not all, patients with broad solid tumors can be salvaged by appropriate multimodality therapy. But long-term survival remains poor, particularly in those with very high disease burden and poor performance status.

Unverified Answer
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