FibroGen Initiates Phase 2 Monotherapy Trial of FG-3246, a First-in-Class CD46 Targeting ADC, in Metastatic Castration-Resistant Prostate Cancer
FibroGen (NASDAQ: FGEN) has launched a Phase 2 monotherapy trial for FG-3246, a first-in-class antibody-drug conjugate (ADC) targeting CD46-expressing cancer lesions in metastatic castration-resistant prostate cancer (mCRPC) patients.
The trial will enroll 75 patients randomized into three dosing groups (1.8, 2.4, or 2.7 mg/kg AJBW) and includes patients who have progressed after ARSI treatment but haven't received chemotherapy. The study will also evaluate FG-3180, a companion PET imaging agent, as a potential diagnostic and predictive biomarker.
An interim analysis is expected in 2H 2026, while topline results from a separate investigator-sponsored study of FG-3246 combined with enzalutamide are anticipated in Q4 2025. The company reports having cash runway extending into 2028.
FibroGen (NASDAQ: FGEN) ha avviato uno studio di fase 2 in monoterapia per FG-3246, un anticorpo-drogha coniugato di prima classe che prende di mira le lesioni tumorali che esprimono CD46 nei pazienti con cancro della prostata metastatico resistente alla castrazione (mCRPC).
Lo studio prevedrà 75 pazienti randomizzati in tre gruppi di dosaggio (1,8, 2,4 o 2,7 mg/kg AJBW) e includerà pazienti che hanno progredito dopo trattamento ARSI ma non hanno ricevuto chemioterapia. Lo studio valuterà anche FG-3180, un agente di imaging PET companion, come potenziale biomarker diagnostico e predittivo.
Un'analisi intermedia è attesa nella seconda metà del 2026, mentre i risultati primari di uno studio sponsorizzato da ricercatori su FG-3246 in combinazione con enzalutamide sono previsti nel Q4 2025. L'azienda riferisce una runway di cassa che arriva fino al 2028.
FibroGen (NASDAQ: FGEN) ha iniciado un ensayo de fase 2 en monoterapia para FG-3246, un conjugado fármaco-anticuerpo (ADC) de primera clase que apunta a lesiones tumorales que expresan CD46 en pacientes con cáncer de próstata metastásico resistente a la castración (mCRPC).
El ensayo inscribirá 75 pacientes aleatorizados en tres grupos de dosis (1,8, 2,4 o 2,7 mg/kg AJBW) e incluirá pacientes que han progresado tras tratamiento ARSI pero que no han recibido quimioterapia. El estudio también evaluará FG-3180, un agente de imagen PET acompañante, como posible biomarcador diagnóstico y predictivo.
Se espera un análisis interino en la segunda mitad de 2026, mientras que se esperan resultados principales de un estudio patrocinado por investigadores sobre FG-3246 en combinación con enzalutamida para el Q4 2025. La empresa reporta una runway de efectivo hasta 2028.
FibroGen (NASDAQ: FGEN)는 FG-3246에 대한 단독 요법 2상 임상시험을 시작했습니다. CD46를 발현하는 암 병변을 표적으로 하는 1급 항체-약물 접합체(ADC)로, 전이성 거세저항성 전립선암(mCRPC) 환자를 대상으로 합니다.
시험은 75명 환자를 3개 용량군(1.8, 2.4, 2.7 mg/kg AJBW)으로 무작위 배정하고, ARSI 치료 후 진행되었으나 화학요법을 받지 않은 환자들을 포함합니다. 또한 동반 PET 영상 대리제 FG-3180을 잠재적 진단 및 예측 바이오마커로 평가합니다.
중간 분석은 2026년 하반기에 예상되며, FG-3246와 엔잘루타마이드의 병용에 대한 연구의 주요 결과는 2025년 4분기에 기대됩니다. 회사는 2028년까지 현금 운용 여력이 있다고 보고합니다.
FibroGen (NASDAQ: FGEN) a lancé un essai de phase 2 en monothérapie pour FG-3246, un conjugué anticorps-médicament (ADC) de première classe ciblant les lésions cancéreuses exprimant CD46 chez les patients atteints de cancer de la prostate métastatique résistant à la castration (mCRPC).
L'essai recrutera 75 patients randomisés en trois groupes de dosages (1,8, 2,4 ou 2,7 mg/kg AJBW) et inclura des patients qui ont progressé après un traitement ARSI mais qui n'ont pas reçu de chimiothérapie. L'étude évaluera également FG-3180, un agent d'imagerie PET compagnon, comme biomarqueur diagnostique et prédictif potentiel.
Une analyse intermédiaire est prévue dans la deuxième moitié de 2026, tandis que les résultats préliminaires d'une étude sponsorisée par des investigateurs sur FG-3246 en association avec l'enzalutamide sont attendus au 4e trimestre 2025. L'entreprise indique disposer d'une trésorerie suffisante jusqu'en 2028.
FibroGen (NASDAQ: FGEN) hat eine Phase-2-Monotherapie-Studie für FG-3246 gestartet, einen Antikörper-Derivat-Konjugat (ADC) erster Klasse, das CD46-exprimierende Krebsherde bei Patienten mit metastasiertem kastrationsresistantem Prostatakrebs (mCRPC) angreift.
Die Studie wird 75 Patienten einschließen, die in drei Dosierungsgruppen randomisiert werden (1,8, 2,4 oder 2,7 mg/kg AJBW) und Patienten umfasst, die nach ARSI-Behandlung Fortschritte zeigten, aber keine Chemotherapie erhalten haben. Die Studie wird auch FG-3180 bewerten, ein begleitendes PET-Imaging-Agent, als potenziellen diagnostischen und prädiktiven Biomarker.
Eine interim Analyse wird in der zweiten Hälfte 2026 erwartet, während die Top-Line-Ergebnisse einer von Forschern unterstützten FG-3246-Studie in Kombination mit Enzalutamid voraussichtlich im Q4 2025 vorliegen werden. Das Unternehmen meldet eine Cash-Runway bis 2028.
FibroGen (المدرجة في ناسداك: FGEN) أطلقت تجربة من المرحلة الثانية كعلاج أحادي لـ FG-3246، وهو مركب مضاد الجسم- الدواء (ADC) من فئة أولى يستهدف آفات السرطان المعبرة عن CD46 لدى مرضى سرطان البروستاتا المتقدم المقاوم للإزالة (mCRPC).
ستشمل التجربة 75 مريضاً عشوائياً في ثلاث مجموعات جرعات (1.8، 2.4، أو 2.7 mg/kg AJBW) وتضم مرضى تقدموا بعد علاج ARSI لكنهم لم يتلقوا العلاج الكيميائي. ستقيّم الدراسة أيضاً FG-3180، وكيل تصوير PET المرافق، كعامل تشخيصي وتنبؤي محتمل.
من المتوقع إجراء تحليل وسيط في النصف الثاني من 2026، بينما من المتوقع نتائج رئيسية من دراسة مموّلة من قبل باحثين حول FG-3246 بالاشتراك مع الإنزلاتاميد في الربع الرابع من 2025. وتشير الشركة إلى وجود قدرة تمويل حتى 2028.
FibroGen (NASDAQ: FGEN) 已启动针对 FG-3246 的 II 期单药试验，这是一种第一类的抗体药物偶联物（ADC），靶向表达 CD46 的癌变病灶，针对转移性去势抵抗性前列腺癌（mCRPC）患者。
试验将招募 75 名患者，随机分为三组剂量（1.8、2.4 或 2.7 mg/kg AJBW），包括在 ARSI 治疗后进展但未接受化疗的患者。研究还将评估 FG-3180，一种伴随的 PET 成像剂，作为潜在的诊断和预测性生物标志物。
预计在 2026 年下半年进行中期分析；关于 FG-3246 与恩扎卢胺联合使用的另一项由研究者赞助的研究的初步结果预计在 2025 年第 4 季发布。公司表示现金跑道可持续至 2028 年。
- First-in-class CD46 targeting ADC showing competitive progression-free survival benefits in Phase 1
- Robust cash runway extending into 2028
- Previous compelling clinical activity in heavily pre-treated patients
- Company's transformation to U.S.-focused organization completed
- Interim analysis results not expected until second half of 2026
- Requires prophylactic G-CSF treatment, indicating potential side effects
Insights
FibroGen advances FG-3246 into Phase 2 for mCRPC with promising previous data and clear development strategy through 2026.
FibroGen has initiated a Phase 2 dose-optimization trial for FG-3246, a first-in-class antibody-drug conjugate (ADC) targeting CD46-expressing cancer lesions in metastatic castration-resistant prostate cancer (mCRPC) patients. This represents a significant advancement in their oncology pipeline following encouraging Phase 1 results that showed compelling clinical activity in heavily pre-treated patients.
The trial design is strategically focused, enrolling 75 patients in the post-androgen receptor signaling inhibitor (ARSI) but pre-chemotherapy setting – a critical treatment window where effective therapies are needed. Patients will be randomized to receive one of three doses (1.8, 2.4, or 2.7 mg/kg AJBW) to determine the optimal dose for future Phase 3 development.
What makes this program particularly innovative is the companion diagnostic approach. The trial incorporates FG-3180, a PET imaging agent sharing the same CD46-targeted antibody as FG-3246, potentially allowing for precision patient selection based on CD46 expression levels. This theranostic approach could significantly enhance treatment outcomes by identifying patients most likely to respond.
The company's financial position appears solid, with a cash runway extending into 2028, providing sufficient resources to advance this asset through key development milestones. The interim analysis expected in 2H 2026 and the near-term readout of the combination study with enzalutamide in Q4 2025 establish clear catalysts for investors to monitor program progress.
The strategic positioning in the treatment paradigm (post-ARSI, pre-chemotherapy) addresses a significant unmet need in prostate cancer management where resistance mechanisms often limit treatment options. If successful, FG-3246 could become an important addition to the mCRPC treatment landscape.
- FG-3246 Phase 2 dose optimization trial to enroll 75 patients with metastatic castration-resistant prostate cancer (mCRPC) in the post-androgen receptor signaling inhibitor (ASRI) and pre-chemotherapy setting
- FG-3180 to be evaluated in the Phase 2 trial as a companion PET imaging agent and a potential predictive patient selection biomarker
- Interim analysis expected in 2H 2026
SAN FRANCISCO, Sept. 24, 2025 (GLOBE NEWSWIRE) -- FibroGen, Inc. (NASDAQ: FGEN) today announced the initiation of the Phase 2 monotherapy, dose-optimization trial of FG-3246, a potential first-in-class antibody-drug conjugate (ADC) targeting CD46-expressing cancer lesions in patients with metastatic castration-resistant prostate cancer (mCRPC). The trial will also assess the diagnostic and predictive performance of FG-3180, a companion PET imaging agent, which shares the same CD46-targeted antibody used in FG-3246. The ability of FG-3180 to identify mCRPC lesions and predict response to FG-3246 will be evaluated.
“With the transformation of FibroGen to a U.S.-focused organization now complete and a robust cash runway into 2028, we are excited to advance our FG-3246 program and initiate the Phase 2 monotherapy trial with the activation of the University of California San Francisco (UCSF) site,” said Thane Wettig, Chief Executive Officer of FibroGen. “FG-3246 demonstrated compelling clinical activity in patients that were heavily pre-treated, with a competitive radiographic progression free survival benefit in the Phase 1 monotherapy study. We are confident that the dosing regimen of FG-3246, use of prophylactic G-CSF, and the enrollment of patients in earlier lines of treatment of mCRPC set us up to further demonstrate the potential of this program. We anticipate results from the interim analysis of our Phase 2 study in the second half of 2026. We also look forward to reporting the results from the ongoing investigator-sponsored study of FG-3246 in combination with enzalutamide in the fourth quarter of this year.”
The Phase 2 monotherapy trial (NCT06842498) is a randomized, open label, dose optimization trial designed to evaluate the safety, efficacy, tolerability, and pharmacokinetics (PK) of FG-3246 for the treatment of patients with mCRPC who have progressed following ARSI treatment and who have not received chemotherapy for their mCRPC. The trial is scheduled to enroll 75 patients who will be randomized 1:1:1 to receive either 1.8, 2.4 or 2.7 mg/kg AJBW of FG-3246. The primary endpoint of the trial is the determination of the optimal dose for the Phase 3 trial based on efficacy, safety, and PK parameters. Secondary endpoints include radiographic progression free survival (rPFS), prostate-specific antigen (PSA) 50 response, and PSA90 response. An interim analysis is planned once 12 patients enrolled in each of the three dose arms have completed 12 weeks on study or discontinued and is anticipated in the second half of 2026. An exploratory sub-study will evaluate FG-3180, a companion PET imaging agent, as a diagnostic radiopharmaceutical. All patients deemed eligible for participation in the Phase 2 trial will participate in the sub-study evaluating FG-3180 prior to randomization.
In addition, topline results from the ongoing investigator-sponsored study of FG-3246 in combination with enzalutamide in patients with mCRPC are expected in the fourth quarter of 2025.
About FG-3246
FG-3246 (FOR46) is a potential first-in-class fully human antibody-drug conjugate (ADC), exclusively in-licensed from Fortis Therapeutics, and is being developed by FibroGen for metastatic castration-resistant prostate cancer and potentially other tumor types. FG-3246 binds to an epitope of CD46, a cell receptor target, that induces internalization upon antibody binding, is present at high levels in prostate cancer and other tumor types and demonstrates very limited expression in most normal tissues. FG-3246 is comprised of an anti-CD46 antibody, YS5, linked to the anti-mitotic agent, MMAE, which is a clinically and commercially validated ADC payload. FG-3246 has demonstrated anti-tumor activity in both preclinical and clinical studies.
FG-3246 is currently in an ongoing Phase 1b/2 study being conducted at UCSF as an investigator-sponsored trial to evaluate FG-3246 in combination with enzalutamide in patients with metastatic castration-resistant prostate cancer (mCRPC). An additional investigator-sponsored radiopharmaceutical marker trial using a zirconium-89 positron emission tomography (PET) tracer for CD46 that utilizes the YS5 antibody is also underway at UCSF. The Phase 2 monotherapy dose optimization trial for FG-3246 in mCRPC was initiated in the third quarter of 2025, with interim results expected in the second half of 2026. FG-3246 is an investigational drug and not approved for marketing by any regulatory authority.
About Metastatic Castration-Resistant Prostate Cancer (mCRPC)
Prostate cancer is the second most common malignancy in men, contributing significantly to male mortality rates. Approximately
About FibroGen
FibroGen, Inc. is a biopharmaceutical company focused on development of novel therapies at the frontiers of cancer biology and anemia. Roxadustat (爱瑞卓®, EVRENZOTM) is currently approved in China, Europe, Japan, and numerous other countries for the treatment of anemia in chronic kidney disease (CKD) patients on dialysis and not on dialysis. The Company continues to evaluate a development plan for roxadustat in anemia associated with lower-risk myelodysplastic syndrome (LR-MDS) in the U.S. FG-3246 (also known as FOR46), a first-in-class antibody-drug conjugate (ADC) targeting CD46 is in development for the treatment of metastatic castration-resistant prostate cancer. This program also includes the development of FG-3180, an associated CD46-targeted PET biomarker. For more information, please visit www.fibrogen.com.
Forward-Looking Statements
This release contains forward-looking statements regarding FibroGen’s strategy, future plans and prospects, including statements regarding its commercial products and clinical programs and those of its collaboration partners Fortis and UCSF. These forward-looking statements include, but are not limited to, statements regarding the efficacy, safety, and potential clinical or commercial success of FibroGen products and product candidates, statements regarding FibroGen’s cash runway, and statements about FibroGen’s plans and objectives. These forward-looking statements are typically identified by use of terms such as “may,” “will”, “should,” “on track,” “could,” “expect,” “plan,” “anticipate,” “believe,” “estimate,” “predict,” “potential,” “continue” and similar words, although some forward-looking statements are expressed differently. FibroGen’s actual results may differ materially from those indicated in these forward-looking statements due to risks and uncertainties related to the continued progress and timing of its various programs, including the enrollment and results from ongoing and potential future clinical trials, and other matters that are described in FibroGen’s most recent Annual Report on Form 10-K and Quarterly Report on Form 10-Q, each as filed with the Securities and Exchange Commission (SEC), including the risk factors set forth therein. Investors are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date of this release, and FibroGen undertakes no obligation to update any forward-looking statement in this press release, except as required by law.
For Investor Inquiries:
David DeLucia, CFA
Senior Vice President and Chief Financial Officer
ir@fibrogen.com
FAQ
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