A Phase I, Open-Label, Dose Escalation and Cohort Expansion Study of BS HH 002.SA in Patients Wit… (NCT04743115) | Clinical Trial Compass
UnknownPhase 1
A Phase I, Open-Label, Dose Escalation and Cohort Expansion Study of BS HH 002.SA in Patients With AML and MDS
66 participantsStarted 2021-02
Plain-language summary
Indication:Relapsed or refractory AML in patients for whom no established treatment options are available (this indication will heretofore be referred to as the protocol AML indication), or adult patients with MDS who are classified as high risk or very high risk according to the Revised International Prognosis Scoring System (IPSS-R).
Number of Investigators and Study Centers:Up to 5 Investigators in the US. Objectives:Dose Escalation Part
Primary Objective:
1. To determine the maximum tolerated dose (MTD) of BS HH 002.SA administered subcutaneously once per day for 12 days of a 28-day cycle.
Secondary Objectives:
2. To provide an initial safety profile of single and multiple cycles of BS HH 002.SA.
3. To assess the pharmacokinetic (PK) profile of BS HH 002.SA.
4. To explore the anti-tumor activity of BS HH 002.SA in patients with the protocol AML indication or high-risk MDS.
5. To explore cytogenetics of the malignant cells in relation to response to BS HH 002.SA.
Cohort Expansion Part
Primary Objectives:
1. To evaluate safety and tolerability of BS HH 002.SA at MTD and/or lower dose level (DL) in selected cohorts of patients with the protocol AML indication or high-risk MDS.
2. To evaluate preliminary anti-tumor activity of BS HH 002.SA at MTD and/or lower DL in selected cohorts of patients with the protocol AML indication or high-risk MDS.
Secondary Objectives:
3. To assess the PK profile of BS HH 002.SA.
4. To explore cytogenetics of the malignant cells in relation to response to BS HH 002.SA.
Study Population:Adult patients with the protocol AML indication or high-risk MDS.
Who can participate
Age range18 Years
SexALL
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Inclusion criteria
✓. Female and male patients ≥18 years of age
✓. Patients with one of the following conditions:
✓. Primary or secondary AML, pathologically confirmed according to World Health Organization (WHO) or IWG classification, who have relapsed or refractory disease and for whom no established treatment options are available, or who are not a candidate for current therapies
✓. High risk or very high risk MDS, as evaluated according to the IPSS R, who are resistant or intolerant to standard treatment and not candidates for transplantation
✓. Patients must be willing to participate in the study and have the ability to understand and adhere to study visit schedule and other protocol procedures. They should be able to comprehend and willing to sign an Informed Consent Form (ICF)
✓. Women of childbearing potential must have two negative pregnancy tests during Screening, the second within 24 hours prior to the first administration of study drug, and must agree to use highly effective physician-approved contraception from Screening to 90 days following the last study drug administration. For the purposes of this study, women with tubal ligations are considered to be of childbearing potential but women who are surgically sterile (hysterectomy) or post menopausal ≥2 years are not considered to be of childbearing potential Note: Post-menopausal is defined as aged more than 50 years and amenorrhea for at least 12 months following cessation of all exogenous hormonal treatment. Women with irreversible surgical sterilization by hysterectomy, bilateral oophorectomy, or bilateral salpingectomy, but not tubal ligation, are acceptable.
What they're measuring
1
Dose Escalation Part: the maximum tolerated dose (MTD) of BS HH 002.SA administered subcutaneously once per day for 12 days of a 28-day cycle.
Timeframe: the first 28 day cycle
2
Cohort Expansion Part: To evaluate safety and tolerability of BS HH 002.SA at MTD and/or lower dose level (DL) in selected cohorts of patients with the protocol AML indication or high-risk MDStreatment
Timeframe: maximum of 12 months
3
Cohort Expansion Part: To evaluate preliminary anti-tumor activity of BS HH 002.SA at MTD and/or lower DL in selected cohorts of patients with the protocol AML indication or high-risk MDS.
✓. Male subjects must be surgically sterile. If male subjects are able to father children, they must use a highly effective physician-approved birth control method from Screening, during the study, and for 90 days after the last dose of study drug. The study physician will inform the subject which birth control methods are acceptable. Vasectomy and sexual abstinence are the recommended birth control methods Note: Female partners of male subjects should not become pregnant during the course of the study as the effects of the study drug on an unborn child and on a breast-fed baby are not known. Male participants will not be allowed to take part in this study if their female partner is trying to become pregnant. If female partner does become pregnant while male partner is taking part in the study, male participants should immediately inform the study physician. The female partner will be asked to sign a Pregnant Partner Data Release Form.
Exclusion criteria
✕. Eastern Cooperative Oncology Group (ECOG) performance status 3 or greater
✕. Known hypersensitivity to study drug or its excipients
✕. Acute promyelocytic leukemia
✕. Administration of any antineoplastic therapy or anti-MDS treatment within at least 2 weeks or 5 half-lives (whichever is greater) of the first dose of BS HH 002.SA, with the exception of hydroxyurea for AML patients which should be discontinued 1 day prior to the first dose of BS HH 002.SA
✕. Participation in other clinical trials within at least 2 weeks of the first BS HH 002.SA dose
✕. Concomitantly receiving other investigational agents
✕. Clinical evidence of active central nervous system leukemia
✕. History of diabetes mellitus and a hemoglobin A1c ≥7.0% as assessed at Screening