[Translation] An open-label, multicenter Phase I/II clinical study to evaluate the safety, tolerability, pharmacokinetic characteristics and preliminary efficacy of HB0036 in the treatment of subjects with advanced solid tumors

评估HB0036在局部晚期或转移性实体肿瘤受试者的安全性和耐受性。并探索最大耐受剂量（MTD）及和/或最佳生物剂量（OBD）/或II期临床研究推荐剂量。

[Translation]

To evaluate the safety and tolerability of HB0036 in subjects with locally advanced or metastatic solid tumors, and to explore the maximum tolerated dose (MTD) and/or optimal biological dose (OBD)/or the recommended dose for Phase II clinical studies.

Start Date-

Sponsor / Collaborator

Shanghai Huaaotai Biopharmaceutical Co., Ltd.

[+1]

NCT05417321 / RecruitingPhase 1/2

A Phase I/II, Open-label, Multicenter Study to Evaluate the Safety, Pharmacokinetics, Pharmacodynamics, and Efficacy of HB0036 in Subjects With Advanced Solid Tumors

It is a Phase I/II, Open-label, Multicenter Study to Evaluate the Safety, Pharmacokinetics, Pharmacodynamics, and Efficacy of HB0036 in Subjects with Advanced Solid Tumors

Start Date25 Aug 2022

Sponsor / Collaborator

Shanghai Huaaotai Biopharmaceutical Co., Ltd.

100 Clinical Results associated with HB-0036

100 Translational Medicine associated with HB-0036

100 Patents (Medical) associated with HB-0036

Literatures (Medical) associated with HB-0036

03 Jul 1995·Proceedings of the National Academy of SciencesQ1 · CROSS-FIELD

Staphylococcal enterotoxins bind H-2Db molecules on macrophages.

Q1 · CROSS-FIELD

Article

Author: Chapes, S K ; Beharka, A A ; Iandolo, J J

We screened a panel of monoclonal antibodies against selected macrophage cell surface molecules for their ability to inhibit enterotoxin binding to major histocompatibility complex class II-negative C2D (H-2b) macrophages. Two monoclonal antibodies, HB36 and TIB126, that are specific for the alpha 2 domain of major histocompatibility complex class I, blocked staphylococcal enterotoxins A and B (SEA and SEB, respectively) binding to C2D macrophages in a specific and concentration-dependent manner. Inhibitory activities were haplotype-specific in that SEA and SEB binding to H-2k or H-2d macrophages was not inhibited by either monoclonal antibody. HB36, but not TIB126, inhibited enterotoxin-induced secretion of cytokines by H-2b macrophages. Lastly, passive protection of D-galactosamine-sensitized C2D mice by injection with HB36 antibody prevented SEB-induced death. Therefore, SEA and SEB binding to the alpha 2 domain of the H-2Db molecule induces biological activity and has physiological consequences.

Global Health Research and Policy

The effect of the capitation policy withdrawal on maternal health service provision in Ashanti Region, Ghana: an interrupted time series analysis

Article

Author: Laar, Kindness ; Kuunibe, Naasegnibe ; Yambah, John Kanyiri ; Mensah, Kofi Akohene ; Opoku, Daniel ; Ofori Boateng, Millicent ; Atinga, Roger Ayimbillah ; Quentin, Wilm

AbstractBackgroundPayment methods are known to influence maternal care delivery in health systems. Ghana suspended a piloted capitation provider payment system after nearly five years of implementation. This study aimed to examine the effects of Ghana’s capitation policy on maternal health care provision as part of lesson learning and bridging this critical literature gap. MethodsWe used secondary data in the District Health Information Management System-2 and an interrupted time series design to assess changes in level and trend in the provision of ANC4+ (visits of pregnant women making at least the fourth antenatal care attendance per month), HB36 (number of hemoglobin tests conducted for pregnant women who are at the 36th week of gestation) and vaginal delivery in capitated facilities-CHPS (Community-based Health Planning and Services) facilities and hospitals. ResultsThe results show that the capitation policy withdrawal was associated with a statistically significant trend increase in the provision of ANC4+ in hospitals (coefficient 70.99 p < 0. 001) but no effect in CHPS facilities. Also, the policy withdrawal resulted in contrasting effects in hospitals and CHPS in the trend of provision of Hb36; a statistically significant decline was observed in CHPS (coefficient − 7.01, p < 0.05) while that of hospitals showed a statistically significant trend increase (coefficient 32.87, p < 0.001). Finally, the policy withdrawal did not affect trends of vaginal delivery rates in both CHPS and hospitals. ConclusionsThe capitation policy in Ghana appeared to have had a differential effect on the provision of maternal services in both CHPS and hospitals; repressing maternal care provision in hospitals and promoting adherence to anemia testing at term for pregnant women in CHPS facilities. Policy makers and stakeholders should consider the possible detrimental effects on maternal care provision and quality in the design and implementation of per capita primary care systems as they can potentially impact the achievement of SDG 3.

100 Deals associated with HB-0036

R&D Status

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
Advanced Malignant Solid Neoplasm	Phase 2	CN	Shanghai Huaaotai Biopharmaceutical Co., Ltd.	25 Aug 2022
Advanced Malignant Solid Neoplasm	Phase 2	US	Shanghai Huaaotai Biopharmaceutical Co., Ltd.	25 Aug 2022
Non-Small Cell Lung Cancer	Phase 2	CN	Shanghai Huaaotai Biopharmaceutical Co., Ltd.	25 Aug 2022
Non-Small Cell Lung Cancer	Phase 2	US	Shanghai Huaaotai Biopharmaceutical Co., Ltd.	25 Aug 2022
Solid tumor	IND Approval	CN	Huabo Biopharm Co Ltd.	18 Aug 2022

Clinical Result

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Evaluation

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT05417321 (phase I/II, ASCO2024)	Phase 1/2	Advanced Malignant Solid Neoplasm	19	HB0036 0.04 mg/kg	pooqapzdmo(nzymvayzse) = ≥10% jbzplzyend (rohyuuovir ) View more	Positive	24 May 2024
				HB0036 0.12 mg/kg

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