Open Label, Multicenter, Phase 1 Study to Evaluate the Maximum Tolerated Dose of Orally Administered CB-03-10 With Dose Expansion Phase, in Subjects With Advanced Solid Tumors

Subjects will undergo baseline evaluation and an assessment of extent of disease.
Subjects in Part 1 (Dose Escalation) will receive escalating doses of CB-03-10 based on a modified Fibonacci schema using a standard oncology 3+3 study design to define an MTD and a RP2D. Plasma PK samples will be collected at predetermined timepoints for all subjects.
Subjects in Part 2 (Dose Expansion) of the study will receive CB-03-10 at the RP2D determined in the Part 1 of the study. The indications included in each group will be determined at the completion of Part 1 of the study by Safety Review Committee (SRC).
Subjects will be evaluated weekly initially (for 2 cycles in Part 1 and for 1 cycle in Part 2) and every 2 weeks thereafter. Reassessment of disease will be conducted at Week 8 and every 8 weeks thereafter. Subjects with evidence of response (partial or complete) will be re-evaluated at least 4 weeks later for confirmation.

Start Date14 Jun 2022

Sponsor / Collaborator

Cosmo Technologies Ltd.

100 Clinical Results associated with CB-03-10

100 Translational Medicine associated with CB-03-10

100 Patents (Medical) associated with CB-03-10

Literatures (Medical) associated with CB-03-10

01 Jan 2002·American Journal of Clinical DermatologyQ2 · MEDICINE

Clinical Pharmacology and Therapeutic Use

Q2 · MEDICINE

Review

Author: Benedetta Brazzini ; Nicola Pimpinelli

Currently, topical glucocorticosteroids are the most frequently used drugs in dermatologic practice. Over the years, research has focused on strategies to optimize potency and, in particular, the anti-inflammatory and immunosuppressive capacity of these drugs, while minimizing adverse effects. However, 'ideal' topical corticosteroids have not yet been synthesized. They should be able to permeate the stratum corneum and reach adequate concentrations in the skin without reaching high serum concentrations. Such characteristics can be obtained by increasing the natural lipophilicity of corticosteroids, e.g. by esterification. In the past, many structural modifications have been made to improve the efficacy of topical corticosteroids to produce drugs with greater potency, although this has often been associated with a higher likelihood of adverse effects. Betamethasone dipropionate and clobetasol propionate, known as fifth-generation corticosteroids, are a typical example of potent molecules that can control specific dermatoses very rapidly, but which are associated with a high risk of topical and systemic adverse effects. Recently, steroid components have been synthesized that aim to have adequate anti-inflammatory effects and minimal adverse effects. The newest topical corticosteroids used for the treatment of different dermatoses and allergic reactions of the respiratory tract (in particular asthma) are budesonide, mometasone furoate, prednicarbate, the di-esters 17,21-hydrocortisone aceponate and hydrocortisone-17-butyrate-21-propionate, methylprednisolone aceponate, alclometasone dipropionate, and carbothioates such as fluticasone propionate. These new topical corticosteroids are evaluated in the current review, which compares the risk/benefit ratio of each molecule with established agents. The new molecules, compared with the well known and established corticosteroids, generally have a higher anti-inflammatory effect, good compliance among patients (only a once-daily application is needed), rarely induce cross-sensitivity reactions and have weak atrophogenicity.

01 Oct 1986·Agents and Actions

Increase in incorporation into lymphocytesin vitro of esterified anti-inflammatory corticosteroids

Article

Author: A. Fujita ; R. Igarashi ; M. Muramatsu ; Y. Mizushima ; K. Hoshi

Corticosteroids esterified at C-17 and C-21 such as hydrocortisone 17-butyrate 21-propionate (HBP) and prednisolone 17-valerate 21-acetate (PVA) inhibited PHA-induced blastogenesis of human blood lymphocytes more intensively than hydrocortisone (HC) and prednisolone (PSL), the parent corticosteroids. When lymphocytes were incubated with HBP or HC, the total amount of HBP incorporated into lymphocytes was much larger than that of HC. The amount of HBP bound specifically to the receptors was also increased, which may be due to the increased concentration of corticosteroid in lymphocytes. These results suggest that the increased incorporation of the esterified corticosteroids into cells would be most important to produce an intensive biological activity.

01 Jan 1986·Drugs under experimental and clinical research

Comparative toxicity study of hydrocortisone 17-butyrate 21-propionate (HBP) ointment and other topical corticosteroids in rats.

Article

Author: Nakane, S ; Kimura, M ; Otomo, S ; Tarumoto, Y

Comparative systemic and topical toxicity in male rats treated on the dorsal skin for 14 consecutive days with a volume of 0.15 g/100 g (body weight) of 0.1% hydrocortisone 17-butyrate 21-propionate (HBP) ointment, 0.05% clobetasol propionate (CP) ointment, 0.1% predonisolone 17-valerate 21-acetate (PVA) ointment and 0.1% diflucortolone valerate (DV) ointment was studied. In all the treated groups body weight gain was suppressed, serum concentration of total cholesterol and triglycerides increased and the lymphatic tissues and skin were atrophic. The DV and CP groups had adrenal atrophy and renal lesions, and the DV group also had gastric and hepatic lesions. The systemic effect of HBP ointment was weaker than that of the other drugs (DV greater than CP much greater than PVA greater than HBP). All the drugs significantly reduced the skin fold thickness in treated areas throughout the application period. The dermal atrophic effect of HBP ointment was also relatively weaker than that of the other drugs. From the above evidence, it was concluded that HBP ointment was less toxic than the other topical corticosteroids.

100 Deals associated with CB-03-10

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Indication	Highest Phase	Country/Location	Organization	Date
Advanced Malignant Solid Neoplasm	Phase 1	US	Cosmo Technologies Ltd.	14 Jun 2022

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