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NCT07477743
Phase Ib study to evaluate the tolerability, safety, pharmacokinetics and preliminary efficacy of HC010 in combination with chemotherapy regimens in patients with advanced gastrointestinal cancer and determine the recommended dose for subsequent studies.
NCT04389281
In this Phase I trial for subjects with advanced head \& neck cancer, breast cancer, soft tissue sarcoma or melanoma all subjects will receive open label X-PACT treatment as a intra-tumoral injection. The primary objective will be to establish the safety of X-PACT when dosed with 5 intra-tumoral injections of the combination product (the phosphor device and methoxsalen sterile solution and subsequently exposing the tumor to X-ray energy) over a period of 6 weeks (on day D1, D3 and D5 of Week 1, on D1 of Week 2, and a booster on D1 of Week 6). After the week 8 tumor assessment subjects demonstrating stable disease, partial response or unconfirmed progression assessed by iRecist, will be eligible to receive two additional booster treatments 4-6 weeks apart. Treatment will be considered safe provided ≤ 2 out of 12 patients experience a dose-limiting toxicity (DLT) during the 6 weeks after the first intra-tumoral injection. Two expansion cohorts have been added to the study. One for TNBC and one for soft tissue sarcoma. 16 additional subjects will be added in each of the expansion cohorts.
NCT07309770
This study is a single-center, multi-cohort, phase II clinical trial. Eligible patients with HER2-positive advanced solid tumors were enrolled after providing informed consent. A total of 90 patients were allocated into three cohorts (30 patients each): those with Extramammary Paget's Disease (EMPD), rare solid tumors, or urothelial carcinoma, who had experienced failure of standard treatment or for whom no standard treatment was available. The participant recruitment period was 12 months, and the follow-up duration was 12 months. All patients received Trastuzumab Rezetecan (SHR-A1811) at a dose of 4.8 mg/kg administered every three weeks (q3w). They were followed until disease progression, withdrawal from the study, loss to follow-up, or death, whichever occurred first. Tumor response was assessed radiologically every 6 weeks during treatment. Safety follow-up was conducted 30 days after the last dose, followed by survival follow-up every 3 months thereafter.
NCT07260513
GH2616 is a potent and selective inhibitor targeting KIF18A, exhibiting distinct and superior anticancer properties compared to other cell cycle and anti-mitotic drug targets, with significant inhibitory effects on TP53 mutant and WGD (whole genome doubling) or CIN (chromosomal instability) tumors. GH2616 regulates chromosome distribution and alignment, prolongs mitotic duration, and activates the spindle assembly checkpoint by inhibiting KIF18A activity, thereby arresting mitosis at the G2/M phase, inducing mitotic catastrophe, and ultimately achieving tumor suppression. This study will evaluate the safety and tolerability of GH2616 in patients with advanced solid tumors, and determine its dose-limiting toxicity (DLT), maximum tolerated dose (MTD), and/or recommended phase II dose (RP2D).